Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:43 PM
Study NCT ID:
NCT07414368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D014456', 'term': 'Ulcer'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of target ulcers achieving complete wound closure during the observational period', 'timeFrame': '1-12 weeks', 'description': 'Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Percent area reduction', 'timeFrame': '1-12 weeks', 'description': 'Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.'}, {'measure': 'Time to closure for the target ulcer', 'timeFrame': '1-12 weeks', 'description': 'Time to closure (days) will be determined from the first device application to the date when the wound is first documented as fully closed.'}, {'measure': 'Adverse Events', 'timeFrame': '1-12 weeks', 'description': 'Incidence of adverse events will be evaluated during each treatment visit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Ulcers', 'Diabetic Foot Ulcers (DFU)', 'DFU', 'Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of hard-to-heal wounds.', 'detailedDescription': 'This is a retrospective, single-center observational case series to assess real-world outcomes of StimLabs dehydrated human umbilical cord particulate used in the management of hard-to-heal wounds, including acute and chronic ulcers. This case series will include real-world data from up to 10 subjects at one participating site. The Corplex P product has been utilized in a variety of patients attending wound clinics for management of partial and full-thickness wounds, pressure ulcers, venous leg ulcers (VLU), diabetic foot ulcers (DFUs), chronic vascular ulcers, and surgical wounds. The device is intended to cover, protect, and provide a moist wound environment. Medical records will be reviewed for subjects who received the Corplex P product, and data will be collected from baseline, first presentation, treatment, and follow up data. Data summaries will review wound closure, percent are reduction in wound size over treatment time, number of device applications required during treatment, time to wound closure, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive subjects receiving Corplex P in a real-world setting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive subjects that received a Corplex P device application during wound management in the following retrospective cohort between February 2024 and November 2025.\n\nExclusion Criteria:\n\n* Subjects not receiving an initial Corplex P application during treatment'}, 'identificationModule': {'nctId': 'NCT07414368', 'briefTitle': 'Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'StimLabs'}, 'officialTitle': 'A Retrospective, Single-center Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate Used for Treatment in Acute and Chronic Wounds', 'orgStudyIdInfo': {'id': 'CXP2601.000-M(01/26)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective Corplex P', 'description': 'Retrospective case review of subjects receiving Corplex P', 'interventionNames': ['Device: Corplex P is used to cover, protect, and provide a moist wound environment']}], 'interventions': [{'name': 'Corplex P is used to cover, protect, and provide a moist wound environment', 'type': 'DEVICE', 'description': 'Corplex P is derived from human birth tissue and used in wound management to cover, protect, and provide a moist wound environment.', 'armGroupLabels': ['Retrospective Corplex P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'contacts': [{'name': 'Denise Riera, DPM', 'role': 'CONTACT', 'phone': '203-334-6955'}, {'name': 'R. Daniel Davis, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Family Foot & Ankle Specialists, LLC', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}], 'centralContacts': [{'name': 'Scott Capps', 'role': 'CONTACT', 'email': 'scott.capps@stimlabs.com', 'phone': '888.346.9802'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'StimLabs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}