Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:40 AM
Study NCT ID:
NCT07360418
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D016523', 'term': 'Foot Ulcer'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Recurrence', 'timeFrame': '52 weeks', 'description': 'To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone.'}], 'secondaryOutcomes': [{'measure': 'Virtual Long-Term Follow Up', 'timeFrame': '52 weeks', 'description': 'To evaluate the effectiveness of virtual clinical trial technology in the conduct of a long-term follow up trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAMPX', 'CAMP', 'Foot Ulcer', 'diabetic foot ulcer'], 'conditions': ['Diabetic Foot Ulcers (DFU)', 'Foot Ulcer Chronic', 'Ulcer', 'Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.', 'detailedDescription': 'This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be drawn from diabetic subjects who have previously completed the CAMPX trial and achieved complete closure.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.\n\nExclusion Criteria:\n\n* The potential subject did not participate in the CAMPX trial.\n* The potential subject participated in the CAMPX trial and did not achieve complete closure.'}, 'identificationModule': {'nctId': 'NCT07360418', 'acronym': 'SCANX', 'briefTitle': 'Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Applied Biologics, LLC'}, 'officialTitle': 'A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial', 'orgStudyIdInfo': {'id': 'Pro00084454'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OneStep Foot Scanner', 'description': 'This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form.', 'interventionNames': ['Other: Blue Drop Foot Scanner']}], 'interventions': [{'name': 'Blue Drop Foot Scanner', 'type': 'OTHER', 'description': 'Subjects with eligible wound will receive a BlueDrop® OneStep Foot Scanner™. They are instructed to step on the scale each morning. The Bluetooth technology transmits a photograph and thermal image to the central monitoring nurse at BlueDrop®. All information transmitted is compliant with HIPPA regulations. Subjects that are unable to use the scale will receive a phone call at months 3,6, 9 and 12 months to determine if the foot has remained closed.', 'armGroupLabels': ['OneStep Foot Scanner']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lina Barman', 'role': 'CONTACT'}], 'facility': 'Detroit Foot and Ankle', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}], 'centralContacts': [{'name': 'Bennett Sarver', 'role': 'CONTACT', 'email': 'info@serenagroups.com', 'phone': '1-833-865-6300'}, {'name': 'Thomas Serena, MD', 'role': 'CONTACT', 'email': 'info@serenagroups.com', 'phone': '1-833-865-6300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Applied Biologics, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Serena Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}