Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04699305
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2021-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reduction in pain at 4 weeks', 'timeFrame': '4 weeks', 'description': 'Pain reduction at 4 weeks for wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT) for patients reporting any level of wound related pain (\\>1 on a VAS scale of 0-10 points) at baseline'}], 'primaryOutcomes': [{'measure': 'Percentage area reduction (PAR) at 4 weeks', 'timeFrame': '4 weeks', 'description': 'Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).'}, {'measure': 'Nature, frequency, and severity of adverse events in the intent to treat population', 'timeFrame': '1 year', 'description': 'Nature, frequency, and severity (by CTCAE5) of adverse events'}], 'secondaryOutcomes': [{'measure': 'Percentage area reduction at 8 and 12 weeks', 'timeFrame': '12 weeks', 'description': 'Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['DFU, PU, Surgical, Vascular, Trauma'], 'conditions': ['Cutaneous Wounds']}, 'referencesModule': {'references': [{'pmid': '35881826', 'type': 'DERIVED', 'citation': 'Williams M, Davidson D, Wahab N, Hawkins J, Wachuku CD, Snyder R. Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers. Wounds. 2022 Jul;34(7):195-200. doi: 10.25270/wnds/21089.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with all types of exuding cutaneous wound', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is ≥18 years of age\n* Subject has an exuding cutaneous wound\n* Subject agrees to the use of his health data, including photos of his wound in analysis and publications\n* Subject/LAR must be able to read and understand English and/or Spanish\n\nExclusion Criteria:\n\n* Subject/LAR is unable to read and understand English or Spanish.'}, 'identificationModule': {'nctId': 'NCT04699305', 'briefTitle': 'Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers', 'organization': {'class': 'INDUSTRY', 'fullName': 'RedDress Ltd.'}, 'officialTitle': 'An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers', 'orgStudyIdInfo': {'id': 'RD005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ActiGraft', 'description': 'Whole blood clot (WBC) gel', 'interventionNames': ['Device: ActiGraft']}], 'interventions': [{'name': 'ActiGraft', 'type': 'DEVICE', 'description': 'Whole blood clot (WBC) gel', 'armGroupLabels': ['ActiGraft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Naz Wahab, M.D', 'role': 'CONTACT'}], 'facility': 'Wound Care Experts', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'centralContacts': [{'name': 'Sharon Sirota', 'role': 'CONTACT', 'email': 'sharon@reddress.co.il', 'phone': '+972545800765'}], 'overallOfficials': [{'name': 'Sharon Sirota', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RedDress Ltd.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Upon publication', 'ipdSharing': 'YES', 'description': 'The results will be part of several scientific publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RedDress Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}