Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-02 @ 11:26 AM
Study NCT ID:
NCT01353495
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2011-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonette.hodge@wmt.com', 'phone': '8002387188', 'title': 'Jonette Hodge, MSN, RN, CCRP, Director, Medical Affairs', 'phoneExt': '4747', 'organization': 'Wright Medical Technology, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Wound Care', 'description': 'Standard Wound care (gels, foams, dressings.)\n\nWound Debridement : Wounds debrided in both arms of study', 'otherNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment With Study Device', 'description': 'Treatment with Biotape Acelular Dermis Graft\n\nAPM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.\n\nWound Debridement : Wounds debrided in both arms of study', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'LT HEEL PAIN WITH POSSIBLE ABSCCESS', 'notes': 'DEVELOPING PAIN LEFT HEEL OVER PAST FEW DAys; MILD FOWL ODOR \\&TENDERNESS. ? INFECTION IN THE HEEL.\n\nReported as possibly related to procedure Final report was resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RT FOOT INFECTION WITH OSTEOMYELITIS', 'notes': 'TO HOSPITAL. CELLULITIS RT LEG, FOOT, WAS PLACED ON IV ABX, BONE SCAN ; POSITIVE OSTEOMYELITIS.\n\nReported as possibly related to procedure final eport: resolved\n\nreported as possibly related to the device; then reported as resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SHORTNESS OF BREATH', 'notes': 'PT STARTED EXPERIENCING INCREASING SOB AND COUGHING AND DECIDED TO GO TO ER TO ENSURE NOTHING WAS WRONG.\n\nNot related to the device or the procedure\n\nOutcome Resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CELLULITIS TO THE RIGHT FOOT.', 'notes': 'SUBJECT HAVING FEVER, CHILLES, AND PAIN. Reported: not related to device or procedure final report: resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DEHYDRATION', 'notes': 'SUBJECT FELL ILL DUE TO FOOD POISONING AND WAS ADMITTED FOR DEHYDRATION OVER THE WEEKEND.\n\nreported as unrelated to device or procedure\n\nOutcome: resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RESPIRATORY FAILURE', 'notes': 'SUBJECT WAS HAVING PROBLEM BREATHING Reported as mild Reported as unrelated to device or procedure Reported as Ongoing at the end of the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DEHYDRATION', 'notes': 'SUBJECT FELL ILL DUE TO FOOD POISONING ADMITTED FOR DEHYDRATION OVER THE WEEKEND.\n\nReported as not related to device or procedure final outcome resolved.\n\nOne foot standard of care other Biotape used', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Study Device', 'description': 'Treatment with Biotape Acelular Dermis Graft\n\nAPM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.\n\nWound Debridement : Wounds debrided in both arms of study'}, {'id': 'OG001', 'title': 'Standard Wound Care', 'description': 'Standard Wound care (gels, foams, dressings.)\n\nWound Debridement : Wounds debrided in both arms of study'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'spread': 'NA', 'comment': 'data not available as the PI left the institution. Every attempt was made to locate the data,', 'groupId': 'OG000'}, {'value': '3.33', 'spread': 'NA', 'comment': 'data not available as the PI left the institution. Every attempt was made to locate the data,', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Wound Care', 'description': 'Standard Wound care (gels, foams, dressings.)\n\nWound Debridement : Wounds debrided in both arms of study'}, {'id': 'FG001', 'title': 'Treatment With Study Device', 'description': 'Treatment with Biotape Acelular Dermis Graft\n\nAPM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.\n\nWound Debridement : Wounds debrided in both arms of study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'subjects with diabetic wound ulcers were recruited for this study in podiatric wound clinic offices for treatment with the graft or standard wound care. Dates of first enrolled subject was 2010', 'preAssignmentDetails': 'an ulcer (UT Grade IIIA-D) index ulcers \\> than 25cm2 an HgA1c \\> 12% within previous 90 days, serum cr 3.0mg/dl known history non-compliance previously into this study, or are in another trial receiving radiation therapy,chemotherapy. known local skin malignancy to the index diabetic ulcer. on anticoagulant medication'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Wound Care', 'description': 'Standard Wound care (gels, foams, dressings.)\n\nWound Debridement : Wounds debrided in both arms of study'}, {'id': 'BG001', 'title': 'Treatment With Study Device', 'description': 'Treatment with Biotape Acelular Dermis Graft\n\nAPM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.\n\nWound Debridement : Wounds debrided in both arms of study'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2011-05-11', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2011-05-12', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-18', 'studyFirstPostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth', 'timeFrame': '12 Weeks', 'description': 'Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic Foot Ulcers'], 'conditions': ['Diabetic Foot Ulcers']}, 'descriptionModule': {'briefSummary': 'Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.', 'detailedDescription': 'The primary objective of this study is time -to - healing with wound size determination at 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria and Population:\n\n* Male or female age 18 or older\n* Informed consent must be obtained\n* Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.\n* Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).\n* Patient's ulcer must exhibit no clinical signs of infection.\n* Patient is of legal consenting age.\n* Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.\n* Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:\n\n * Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR\n * ABIs with results of ≥0.7 and ≤1.2, OR\n * Doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg\n\nExclusion Criteria:\n\n* Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.\n* Patients whose index diabetic foot ulcers are greater than 25cm2.\n* Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days,\n* Patients whose serum creatinine levels are 3.0mg/dl or greater.\n* Patients with a known history of poor compliance with medical treatments.\n* Patients who have been previously randomized into this study, or are presently participating in another clinical trial\n* Patients who are currently receiving radiation therapy or chemotherapy.\n* Patients with known or suspected local skin malignancy to the index diabetic ulcer.\n* Patients on anticoagulant medication will as in any surgical procedure, be monitored According to the protocols employed at the enrolling center.\n* Patients diagnosed with autoimmune connective tissues diseases.\n* Nonrevascularable surgical sites\n* Active infection at site\n* Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin\n* Any pathology that would limit the blood supply and compromise healing;\n* Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days"}, 'identificationModule': {'nctId': 'NCT01353495', 'briefTitle': 'Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': '009-BIO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APM Graft (BIOTAPE XMTM', 'description': 'graft applied to wound q 3 weeks for 12 weeks', 'interventionNames': ['Device: APM Graft (BIOTAPE XMTM)', 'Other: Wound Debridement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard wound care', 'description': 'Wound debridement and gels and foams applied to wound weekly for 12 weeks.', 'interventionNames': ['Other: Wound Debridement']}], 'interventions': [{'name': 'APM Graft (BIOTAPE XMTM)', 'type': 'DEVICE', 'otherNames': ['BIOTAPE XMTM'], 'description': 'Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.', 'armGroupLabels': ['APM Graft (BIOTAPE XMTM']}, {'name': 'Wound Debridement', 'type': 'OTHER', 'description': 'Wounds debrided in both arms of study', 'armGroupLabels': ['APM Graft (BIOTAPE XMTM', 'standard wound care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93722', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Foot Care and Clinincal Research Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Professional Education & Research Institute', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}], 'overallOfficials': [{'name': 'Jagpreet Mukker, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Foot Care and Clinincal Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}