Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-01 @ 4:48 PM
Study NCT ID:
NCT07020559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogeneic vs Autologous PRP for Diabetic Wounds in Renal Dysfunction: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-06', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the wound healing rate at 4 weeks', 'timeFrame': 'by the end of 4 weeks', 'description': 'calculated as the percentage of healed wounds by the end of 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic wounds', 'Platelet Rich Plasma', 'allogeneic blood', 'renal dysfunction'], 'conditions': ['Diabetic Wounds', 'Platelet Rich Plasma', 'Allogeneic Blood Transfusions', 'Renal Dysfunction']}, 'descriptionModule': {'briefSummary': 'Diabetic wounds are difficult to heal. Autologous platelets in diabetic patients with renal insufficiency have poor function. Allogeneic platelet plasma has a promising application prospect. Comparing the efficacy and safety differences between allogeneic platelet plasma and autologous platelet plasma is of significant importance and value for the clinical application.', 'detailedDescription': 'This study is a single-center, randomized, parallel control, superior trial. Fifty-six renal dysfunction patients with diabetic-related wound after wound bed preparation will be randomly assigned to the autologous platelet plasma group and allogeneic platelet plasma group in a 1:1 ratio. The primary outcome is the wound healing rate at 4 weeks (Stitches removal). The secondary outcomes include the wound healing rates at 3 weeks, the reduction rate of wound area at 2-, 3- and 4- weeks, healing time, post-operative wound infection, 7-day, 2-, 3-, 4-week pain relief progression assessed by Visual Analog Scale, incidence of mortality, reoperation, and adverse events during the follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient is aged 18-80 years old;\n2. Diagnosed as type 1 or type 2 diabetes according to the World Health Organization standard, blood sugar has been controlled before enrollment, and the level of Glycated hemoglobin HbA1c is less than 10%;\n3. Abnormal renal function defined as:\n\n * Serum creatinine \\>106 μmol/L (men) or \\>97 μmol/L (women)\n * AND eGFR \\<90 mL/min/1.73m² (CKD-EPI) ；\n4. The patient has diabetes wounds with poor healing or prolonged healing need standard wound treatment;\n5. After preparing the wound bed, the condition for using platelet plasma to close the wound is met\\*;\n6. Voluntarily sign an informed consent form;\n\nExclusion Criteria:\n\n1. Blood glucose is out of control or not yet effectively controlled，;\n2. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;\n3. Active bleeding inside the wound, and routine basic treatment plans cannot be implemented；\n4. Uncontrolled systemic or disseminated infections;\n5. Patients with advanced malignant tumors;\n6. Pregnant or lactating women；\n7. The patient is unable to cooperate or has mental disorders;\n8. According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.'}, 'identificationModule': {'nctId': 'NCT07020559', 'briefTitle': 'Allogeneic vs Autologous PRP for Diabetic Wounds in Renal Dysfunction: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Comparing Allogeneic Versus Autologous Platelet-Rich Plasma for Diabetic Wound Healing in Patients With Renal Dysfunction：a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Long2025-DW-alPRP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'autologous platelet plasma group', 'description': 'diabetic-related wounds after wound bed preparation are treated by the autologous platelet plasma', 'interventionNames': ['Drug: autologous platelet plasma']}, {'type': 'EXPERIMENTAL', 'label': 'allogeneic platelet plasma group', 'description': 'diabetic-related wounds after wound bed preparation are treated by the allogeneic platelet plasma', 'interventionNames': ['Drug: allogeneic platelet plasma']}], 'interventions': [{'name': 'allogeneic platelet plasma', 'type': 'DRUG', 'description': 'Al-PRP derived from healthy blood donors', 'armGroupLabels': ['allogeneic platelet plasma group']}, {'name': 'autologous platelet plasma', 'type': 'DRUG', 'description': 'Autologous platelet-rich plasma from the patient themselves', 'armGroupLabels': ['autologous platelet plasma group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yunfeng Li, Medical Doctor', 'role': 'CONTACT', 'email': 'liyunfeng1106@163.com'}, {'name': 'Yunfeng Li, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Long Zhang Executive Deputy Director, Medical Doctor', 'role': 'CONTACT', 'email': 'liyunfeng1106@163.com', 'phone': '+86 010-82266699'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Wound Healing Center', 'investigatorFullName': 'Long Zhang', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}