Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2026-01-02 @ 2:10 PM
Study NCT ID:
NCT02134132
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2014-05-07', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '3 months', 'description': 'Evaluation the pain reduction by VAS measurement in patients with peripheral artery Disease.'}, {'measure': 'ABI', 'timeFrame': '3 months', 'description': 'Evaluation the Ankle Brakial Index (ABI) in patients 3 months after PG utilization.'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '3months', 'description': 'Evaluation the quality of life by SF36 measurement in patients with PAD.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Platelet gel', 'diabetic foot ulcer', 'umbilical cord blood'], 'conditions': ['Diabetic Foot Ulcers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://Royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Diabetes is a multiorgan disease and considered a major health problem in different societies. One of the complications the pain particularly in the extremities resulting from a process known as diabetic foot ulcer. The diabetic patients are subjected to many complications because of foot ulcers, many of them like as chronic wound disease or pressure ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to nursing care and take too long until pain relief. Among many tested materials and works for wound healing such as debridement, tissue oxygenation, and skin transplantation, platelet-derived compounds are allocated the pivotal position between investigators to tissue regeneration and shortening the wound healing process.\n\nMany of platelet components are procured from platelet rich plasma (PRP) from whole blood donation. Furthermore, it requires to an additional purification step to diminish the volume and facilitate handling in some studies. It means that platelet concentrates (PCs) may be obtained leading to more concentrated platelets in lower volume.\n\nTwo types of granules in platelet is responsible for storage of many useful and different growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the ability to growth and differentiation of numerous cells. Also, the antibacterial effect of these growth factors has been reported.\n\nTo better efficacy and comfortable utilization of platelet, it is feasible to form the platelet gel and then apply on wound sites.\n\nThis study is a double blind randomized controlled trial to evaluate the positive effects of umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.', 'detailedDescription': 'In this study all qualified patients (based on the inclusion and exclusion criteria) were randomly allocated into three study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma gel, group B (placebo) received platelet poor plasma gel, and group C received lubricant gel.\n\nAll of the patients underwent a standard long protocol for knee osteoarthritis. All patients with diabetic foot ulcer are selected.On average,in each instance, the amount of platelets in the peripheral bloodis4 to6 times the baseline level.\n\nGroup A (interventional): application of 20-30mL of gel from platelet rich plasma (PRP) Group B (placebo): application of 20-30mL of gel from platelet poor plasma (PRP) Group C (control): application of 20-30 mL of lubricant gel (used typically for sonography)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of at least 4 weeks hospitalization\n* Uncontrolled diabetes\n* ejection fraction \\> 30%\n\nExclusion Criteria:\n\n* mechanical origin for wound\n* history of infectious, systemic diseases, Immune deficiency and coagulation disorders'}, 'identificationModule': {'nctId': 'NCT02134132', 'briefTitle': 'Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Utilization of Umbilical Cord Blood-derived Platelet Gel for Treatment of Diabetic Foot Ulcers,a Randomized Double Blind Clinical Trial', 'orgStudyIdInfo': {'id': 'Royan-PVD-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'platelet rich plasma', 'description': 'The patients with diabetic foot ulcer who receive PG treatment.', 'interventionNames': ['Biological: Platelet Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patients with diabetic foot ulcer who receive placebo.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Platelet Gel', 'type': 'BIOLOGICAL', 'description': 'Application of platelet gel in patients suffering from diabetic foot ulcers.', 'armGroupLabels': ['platelet rich plasma']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The patients with Diabetic foot ulcer who receive placebo instead of PL Gel.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Royan Institute'}, {'name': 'Nasser Aghdami, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of regenerative medicine department &cell therapy center of Royan Institute'}, {'name': 'Behnam Molavi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of vascular & Trauma Surgery of Sina Hospital'}, {'name': 'Seyedeh Esmat Hosseini, Bs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Regenerative Medicine & cell therapy of Royan Institute'}, {'name': 'Alireza Goodarzi, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Regenerative Medicine of Royan Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}