Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:41 PM
Study NCT ID:
NCT07420868
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Reduction in Index Ulcer Area', 'timeFrame': 'Baseline to Week 6', 'description': 'Percentage change in ulcer surface area from baseline to Week 6, measured by standardized planimetry using either transparent grid tracing or calibrated digital photography with software-based area calculation. The same measurement method will be applied consistently for each participant.'}], 'secondaryOutcomes': [{'measure': 'Complete Epithelialization of the Index Ulcer', 'timeFrame': 'Up to Week 6', 'description': 'Proportion of index ulcers achieving complete epithelialization (full wound closure) within the 6-week follow-up period, documented at scheduled visits.'}, {'measure': 'Time to Complete Healing of the Index Ulcer', 'timeFrame': 'Up to Week 6', 'description': 'Time (in days) from randomization/baseline to first documented complete epithelialization among index ulcers that achieve closure during follow-up.'}, {'measure': 'Change in Ulcer-Related Pain Score', 'timeFrame': 'Baseline and weekly assessments through Week 6', 'description': 'Change in pain severity assessed using a Visual Analogue Scale from 0 to 10, recorded at baseline and at each follow-up visit, with change calculated from baseline to each subsequent visit and to Week 6.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet Rich Plasma', 'Normal Saline Dressing', 'Wound Healing', 'Ulcer Area Reduction', 'Complete Epithelialization'], 'conditions': ['Chronic Skin Ulcer', 'Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will compare platelet rich plasma dressing with normal saline dressing for the treatment of chronic non healing cutaneous ulcers, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, and other suitable chronic ulcers of at least six weeks duration. A total of 100 adults will be recruited from the Department of Dermatology, Multan Medical and Dental College, and allocated in a 1:1 ratio to receive either autologous platelet rich plasma dressing or normal saline dressing for six weeks, with both groups receiving the same standardized wound care package including debridement when indicated, infection control, moisture balance, and etiology specific supportive measures such as offloading or compression. The hypothesis is that platelet rich plasma dressing will lead to greater wound healing by supplying concentrated platelets and naturally occurring growth factors that support granulation tissue formation and re epithelialization. The primary outcome is the percentage reduction in ulcer area from baseline to the end of follow up, measured using standardized planimetry. Secondary outcomes include the proportion of ulcers achieving complete epithelialization within the follow up period, time to complete healing among ulcers that close, and change in pain scores during treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or above\n* Either gender\n* Chronic non healing cutaneous ulcer of at least 6 weeks duration\n* Ulcer etiology eligible for conservative dressing-based management, including\n* Diabetic foot, Venous leg and Pressure ulcer\n* Other chronic ulcers considered suitable by the treating dermatologist\n* Measurable index ulcer surface area suitable for standardized photography and planimetric assessment\n* Clinically acceptable wound bed after initial wound bed preparation\n* No requirement for urgent surgical reconstruction at enrolment\n* Ability to attend twice weekly dressing visits for 6 weeks\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Suspected or proven malignant ulceration\n* Vasculitic or inflammatory ulcers requiring systemic immunosuppression\n* Pyoderma gangrenosum\n* Critical limb ischemia or severe perfusion compromise on clinical assessment, with vascular screening where feasible\n* Requirement for urgent revascularization\n* Active osteomyelitis requiring bony debridement\n* Exposed bone with high suspicion of osteomyelitis\n* Rapidly spreading soft tissue infection\n* Systemic sepsis\n* Hematological abnormalities making venesection or platelet rich plasma preparation unsafe, including\n* Clinically relevant platelet dysfunction\n* Known bleeding diathesis\n* Therapeutic anticoagulation where temporary interruption is not clinically appropriate\n* Pregnancy or lactation\n* Participation in another interventional wound trial\n* Inability to comply with follow up'}, 'identificationModule': {'nctId': 'NCT07420868', 'briefTitle': 'Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Multan Medical And Dental College'}, 'officialTitle': 'Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers', 'orgStudyIdInfo': {'id': 'MMDC1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Platelet Rich Plasma Dressing', 'description': 'Received autologous platelet rich plasma applied topically to the ulcer bed after standard wound cleansing with normal saline and debridement when indicated, followed by a non adherent secondary dressing, absorbent padding, and fixation bandage. Supportive measures such as offloading for neuropathic or pressure related ulcers and compression therapy for venous leg ulcers were provided as indicated, using the same standardized care package as the comparator arm.', 'interventionNames': ['Biological: Platelet Rich Plasma Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Normal Saline Dressing', 'description': 'Received ulcer cleansing with normal saline followed by sterile gauze moistened with normal saline, then the same standardized secondary dressing and fixation method used in the experimental arm. Supportive measures including debridement when indicated, infection management, moisture balance, offloading, and compression therapy were provided according to ulcer etiology using the same standardized care package as the experimental arm.', 'interventionNames': ['Other: Normal Saline Dressing']}], 'interventions': [{'name': 'Platelet Rich Plasma Dressing', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous platelet rich plasma wound dressing'], 'description': 'Autologous platelet rich plasma prepared under aseptic conditions using a standardized double centrifugation method and applied evenly over the entire wound bed at scheduled dressing visits for 6 weeks, with interim secondary dressing changes as clinically indicated based on exudate, using the same secondary dressing type across participants.', 'armGroupLabels': ['Group Platelet Rich Plasma Dressing']}, {'name': 'Normal Saline Dressing', 'type': 'OTHER', 'otherNames': ['Saline moistened gauze dressing'], 'description': 'Normal saline cleansing and sterile gauze dressing moistened with normal saline applied at scheduled dressing visits for 6 weeks, with additional dressing changes permitted if clinically indicated due to exudate soakage, and all changes documented.', 'armGroupLabels': ['Group Normal Saline Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Multan Medical and Dental College', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'overallOfficials': [{'name': 'Saba Amin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multan Medical And Dental College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Multan Medical And Dental College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Saba Amin', 'investigatorAffiliation': 'Multan Medical And Dental College'}}}}