Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT06873867
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2025-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'naveen_uno1@yahoo.co.in', 'phone': '+91-9980023372', 'title': 'Dr Naveen N', 'organization': 'Adichunchanagiri Institute of Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The single-center design may limit generalizability.\n\nComplete blinding was not feasible due to the nature of interventions, potentially introducing bias, although outcome assessor blinding was maintained.\n\nThe 7-week study period, while adequate for assessing acute healing outcomes, may not capture long-term benefits or complications such as recurrence rates, functional outcomes'}}, 'adverseEventsModule': {'timeFrame': '6-week treatment period + 1-week follow-up. Total 7 weeks', 'description': 'All the study participants were considered at risk for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 5, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 8, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Superficial wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation around wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NPWT seal issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain during dressing change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Wound Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'title': 'Wound area reduction at 1 week', 'categories': [{'measurements': [{'value': '23.73', 'spread': '11.45', 'groupId': 'OG000'}, {'value': '15.21', 'spread': '9.32', 'groupId': 'OG001'}]}]}, {'title': 'Wound area reduction at 2 weeks', 'categories': [{'measurements': [{'value': '34.47', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '22.52', 'spread': '10.85', 'groupId': 'OG001'}]}]}, {'title': 'Wound area reduction at 3 weeks', 'categories': [{'measurements': [{'value': '45.17', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '29.85', 'spread': '11.98', 'groupId': 'OG001'}]}]}, {'title': 'Wound area reduction at 4 weeks', 'categories': [{'measurements': [{'value': '56.45', 'spread': '15.82', 'groupId': 'OG000'}, {'value': '36.62', 'spread': '12.74', 'groupId': 'OG001'}]}]}, {'title': 'Wound area reduction at 5 weeks', 'categories': [{'measurements': [{'value': '67.14', 'spread': '16.45', 'groupId': 'OG000'}, {'value': '43.97', 'spread': '13.28', 'groupId': 'OG001'}]}]}, {'title': 'Wound area reduction at 6 weeks', 'categories': [{'measurements': [{'value': '78.33', 'spread': '16.98', 'groupId': 'OG000'}, {'value': '50.83', 'spread': '13.72', 'groupId': 'OG001'}]}]}, {'title': 'Wound area reduction at 7 weeks', 'categories': [{'measurements': [{'value': '89.35', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '57.85', 'spread': '12.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Percentage change in wound area from week 1 through week 7 measured manually with digital photography', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Histopathological Analysis on Day 5 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'title': 'vascular infiltration (0-3 scale)', 'categories': [{'measurements': [{'value': '2.82', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'neo-epithelialization (0-3 scale)', 'categories': [{'measurements': [{'value': '2.73', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'fibroblast activity (0-3 scale)', 'categories': [{'measurements': [{'value': '2.79', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'inflammatory response (0-3 scale)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'collagen deposition (0-3 scale)', 'categories': [{'measurements': [{'value': '2.78', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for:\n\nvascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Histopathological Analysis on Day 5 of Study - Capillary Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '48.51', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '42.97', 'spread': '7.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better,', 'unitOfMeasure': 'vessels per mm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Complete Wound Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '36.81', 'spread': '12.88', 'groupId': 'OG000'}, {'value': '43.94', 'spread': '16.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'The time to achieve complete wound closure of the target ulcer by the end of 7 weeks', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants to Obtain Complete Wound Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 weeks', 'description': 'The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ≥50% Wound Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 weeks', 'description': 'Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Number of Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.83', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Mean number of rapplications of the NPWT+HPTC \\& NPWT alone used to obtain wound closure', 'unitOfMeasure': 'number of applications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'title': 'Superficial wound infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Skin irritation around wound', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NPWT seal issues', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Allergic reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain during dressing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Severe infection requiring IV antibiotics', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)', 'unitOfMeasure': 'number of adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score on Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.38', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '6.36', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '5.71', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '5.97', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '4.73', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.98', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '2.86', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '4.28', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '1.96', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '1.51', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0="no pain" to 10="severe pain"', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Healed Wound Appearance Assessment Using Vancouver Scar Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'The resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'classes': [{'title': 'EQ-5D Index Score', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.116', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS (0-100)', 'categories': [{'measurements': [{'value': '88.2', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '72.1', 'spread': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.\n\nScoring and Ranges:\n\n1. EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems).\n\n The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health).\n2. EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes.\n\nInterpretation:\n\nHigher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'FG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.\n\nHigh Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'BG001', 'title': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.\n\nNegative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.1', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Patients aged 18-80 years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Wound area (cm²)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.8', 'spread': '18.5', 'groupId': 'BG000'}, {'value': '33.6', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '33.18', 'spread': '18.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'square centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wound duration (weeks)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wound etiology, n (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Traumatic', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Surgical', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Diabetic', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Burns', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Vascular', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Pressure', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Wound location, n (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Lower Limb', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Chest', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Upper limb', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Abdomen', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Back', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Head and Neck', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-09', 'size': 200068, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-10T01:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2025-03-03', 'resultsFirstSubmitDate': '2025-10-10', 'studyFirstSubmitQcDate': '2025-03-07', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-10', 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Wound Area', 'timeFrame': '7 weeks', 'description': 'Percentage change in wound area from week 1 through week 7 measured manually with digital photography'}], 'secondaryOutcomes': [{'measure': 'Histopathological Analysis on Day 5 of Study', 'timeFrame': '5 days', 'description': 'Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for:\n\nvascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better'}, {'measure': 'Histopathological Analysis on Day 5 of Study - Capillary Density', 'timeFrame': '5 days', 'description': 'Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better,'}, {'measure': 'Time to Achieve Complete Wound Closure', 'timeFrame': '7 weeks', 'description': 'The time to achieve complete wound closure of the target ulcer by the end of 7 weeks'}, {'measure': 'Percentage of Participants to Obtain Complete Wound Closure', 'timeFrame': '7 weeks', 'description': 'The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up)'}, {'measure': 'Percentage of Participants Achieving ≥50% Wound Healing', 'timeFrame': '7 weeks', 'description': 'Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up'}, {'measure': 'Mean Number of Application', 'timeFrame': '6 weeks', 'description': 'Mean number of rapplications of the NPWT+HPTC \\& NPWT alone used to obtain wound closure'}, {'measure': 'Number of Adverse Events', 'timeFrame': '6 weeks', 'description': 'Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)'}, {'measure': 'Pain Score on Visual Analog Scale', 'timeFrame': '7 weeks', 'description': 'Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0="no pain" to 10="severe pain"'}, {'measure': 'Healed Wound Appearance Assessment Using Vancouver Scar Scale', 'timeFrame': '7 weeks', 'description': 'The resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar)'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '7 weeks', 'description': 'The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.\n\nScoring and Ranges:\n\n1. EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems).\n\n The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health).\n2. EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes.\n\nInterpretation:\n\nHigher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Full Thickness Skin Defects', 'Ulcer', 'Negative Pressure Wound Therapy', 'High Purity Type 1 Collagen', 'Helicoll'], 'conditions': ['Full Thickness Skin Defects', 'Ulcer']}, 'referencesModule': {'references': [{'pmid': '17425550', 'type': 'BACKGROUND', 'citation': 'Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.'}, {'pmid': '36796046', 'type': 'BACKGROUND', 'citation': 'Lee SK, An YS, Choy WS. Management of Hardware-Exposed Soft Tissue Defects Using Dermal Substitutes and Negative Pressure Wound Therapy. Ann Plast Surg. 2023 Mar 1;90(3):242-247. doi: 10.1097/SAP.0000000000003440.'}, {'pmid': '33344649', 'type': 'BACKGROUND', 'citation': 'Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020.'}, {'type': 'BACKGROUND', 'citation': 'Dhanraj P, Naveen N, Babu KR, Mahesh MS Hanumanthaiah KS. Healicoll: An Alternate to Flap Cover for Bare Bones and Tendons. Acta Medica International, 2016; 3(1): 146-150'}, {'pmid': '39649230', 'type': 'BACKGROUND', 'citation': 'Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.'}]}, 'descriptionModule': {'briefSummary': 'Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.', 'detailedDescription': 'Full-thickness wounds, extending through the dermis and affecting underlying tissues, present significant clinical challenges due to their complexity and prolonged healing times. Traditional treatments include surgical debridement, dressings, and advanced therapies like Negative Pressure Wound Therapy (NPWT). Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. Studies suggest that HPTC promote cellular proliferation and angiogenesis, essential for tissue regeneration. Given the distinct mechanisms of action of NPWT and HPTC, a comparative evaluation is warranted to determine their relative efficacy in treating full-thickness wounds. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. Presence of a full-thickness wound of at least 4 cm² and no more than 100 cm².\n3. Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit.\n4. Adequate vascular supply to the affected area\n5. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n6. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.\n7. The subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. A subject known to have a life expectancy of \\<6 months\n2. Wounds with active infection / osteomyelitis requiring systemic antibiotics.\n3. Presence of malignancy in the wound bed.\n4. Patients with uncontrolled diabetes (HbA1c \\> 9%).\n5. Use of immunosuppressive therapy or systemic corticosteroids.\n6. Use of other advanced wound care products within the past 30 days\n7. Known allergy to fish products or components of HPTC.\n8. Pregnant or breastfeeding women.\n9. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.\n10. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.\n11. A subject with autoimmune or connective tissue disorders.\n12. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days."}, 'identificationModule': {'nctId': 'NCT06873867', 'briefTitle': 'Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone', 'organization': {'class': 'OTHER', 'fullName': 'Adichunchanagiri Institute of Medical Sciences, B G Nagara'}, 'officialTitle': 'A Comparative Analysis in Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone', 'orgStudyIdInfo': {'id': 'AIMS/IEC/013/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.', 'interventionNames': ['Device: High Purity Type-I Collagen based Skin Substitute', 'Device: Negative Pressure Wound Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Negative Pressure Wound Therapy', 'description': 'In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.', 'interventionNames': ['Device: Negative Pressure Wound Therapy']}], 'interventions': [{'name': 'High Purity Type-I Collagen based Skin Substitute', 'type': 'DEVICE', 'description': 'In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed', 'armGroupLabels': ['High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy']}, {'name': 'Negative Pressure Wound Therapy', 'type': 'DEVICE', 'description': 'In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed', 'armGroupLabels': ['High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy', 'Negative Pressure Wound Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '571448', 'city': 'Mandya', 'state': 'Karnataka', 'country': 'India', 'facility': 'Adichunchanagiri Institute of Medical Sciences', 'geoPoint': {'lat': 12.5223, 'lon': 76.89746}}], 'overallOfficials': [{'name': 'Prema Dhanraj, MS, MCh', 'role': 'STUDY_CHAIR', 'affiliation': 'Rajarajeshwari Medical College and Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adichunchanagiri Institute of Medical Sciences, B G Nagara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery', 'investigatorFullName': 'Dr Naveen Narayan MS, MCh (Plastic Surgery)', 'investigatorAffiliation': 'Adichunchanagiri Institute of Medical Sciences, B G Nagara'}}}}