Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT05046158
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2021-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001458', 'term': 'Bandages'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-09-07', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of wound closure', 'timeFrame': '12 weeks', 'description': 'Compare rate of complete wound healing in diabetic foot wounds between the two study groups'}], 'secondaryOutcomes': [{'measure': 'Wound healing trajectories and time to wound closure', 'timeFrame': '12 weeks', 'description': 'Evaluate differences in wound healing trajectories and time to wound closure between the two study groups'}, {'measure': 'Adverse Events', 'timeFrame': '12 weeks', 'description': 'Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections'}, {'measure': 'Subject Satisfaction', 'timeFrame': '12 weeks', 'description': 'Evaluate subject satisfaction of wound care products based on "Research subject satisfaction survey" completed at the end of study (8 questions total using a 7 point Likert scale).'}, {'measure': 'Wound pain', 'timeFrame': '12 weeks', 'description': 'Compare differences in pain between the groups based on results of a validated 10 point "Visual Analogue Pain Scale" completed at each visit by all subjects. More pain is indicated by higher scores.'}, {'measure': 'Quality of Life while living with a wound', 'timeFrame': '12 weeks', 'description': 'Compare differences in quality of life between the groups based on results of completed validated "Wound Quality of Life Questionnaire for Chronic Wounds" (17 questions total, answering a 5 point scale \\[not at all to very much\\], results from answers based on formula)'}, {'measure': 'Clinician Acceptability', 'timeFrame': '12 weeks', 'description': 'Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Standard of Care Wound Dressings', 'Transforming Powder Dressing', 'Diabetic Foot Ulcers', 'Altrazeal'], 'conditions': ['Diabetic Foot Ulcer']}, 'referencesModule': {'references': [{'pmid': '32176447', 'type': 'BACKGROUND', 'citation': 'Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.'}, {'pmid': '28108895', 'type': 'BACKGROUND', 'citation': 'Han G, Ceilley R. Chronic Wound Healing: A Review of Current Management and Treatments. Adv Ther. 2017 Mar;34(3):599-610. doi: 10.1007/s12325-017-0478-y. Epub 2017 Jan 21.'}, {'type': 'BACKGROUND', 'citation': 'Wound Care Awareness Week Highlights of the Chronic Wound Epidemic in U.S. Businesswire.com/news/home/20160607006326/en/Wound-Care-Awareness-Week-Highlights-Chronic-Wound. Accessed 11/5/2020.'}], 'seeAlsoLinks': [{'url': 'http://www.Altrazeal.info', 'label': 'Altrazeal (Transforming Powder Dressing) product information'}]}, 'descriptionModule': {'briefSummary': 'Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.', 'detailedDescription': 'Diabetic men and women aged 18-89 years, who have a diabetic foot ulcer present for a minimum of 30 days will be considered for the study. Subjects will be randomized to either standard of care wound dressings or transforming powder dressing. Half of the subjects will receive standard of care dressings, and the other half will receive transforming powder dressing in a 1:1 randomization process at each of the study sites. Subjects will present to the study center weekly for up to 12 weeks (less time if the wound heals prior to 12 weeks). The last study visit occurs 12 weeks after the End of Study visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-89 years old\n* Diagnosed with diabetes Mellitus; hemoglobin A1C \\< 12%\n* Diabetic foot ulcer present for minimum 30 days (Wagner grade 1 or 2 classification)\n* Wound drainage is minimal or moderate\n* No clinically active wound infection\n* Able and willing to provide consent\n* Has not participated in another research trial within 3 months of enrollment.\n\nExclusion Criteria:\n\n* Unable to keep weekly research appointments\n* Unable or unwilling to use offloading device if recommended\n* Wounds with large amount (high) drainage\n* Active gangrene\n* Wounds impending surgical intervention (including revascularization or plastic surgery)\n* Untreated osteomyelitis\n* Soft tissue infection (can be enrolled once infection is cleared)\n* Active Charcot arthropathy\n* BMI \\>45kg/m2\n* History of AIDS\n* History of organ transplant or impending transplant\n* End stage renal disease requiring dialysis\n* Decompensated hepatic or cardiac disease\n* Select autoimmune diseases\n* Lymphedema\n* Oral steroid use in last 3 months\n* Venous stasis disease\n* Active malignancy (cancer)\n* Unable to sign consent\n* Active alcohol or substance abuse\n* Pregnant or lactating women\n* Insufficient vascular flow to heal a wound\n* Hemoglobin A1C \\>12%'}, 'identificationModule': {'nctId': 'NCT05046158', 'briefTitle': 'Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'ULURU Inc.'}, 'officialTitle': 'Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'U-C-TPD-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transforming Powder Dressing', 'description': 'Half of the subjects will be randomized to Transforming Powder Dressing to treat their diabetic foot ulcers. Wounds will be evaluated weekly, debrided if needed, photographed, and measured. A wound dressing will be applied using Transforming Powder Dressing and the wound will be offloaded when necessary (pressure taken off of the wound using a total contact cast or other device). Wound healing progress will be monitored and compared to other standard of care dressings used to treat diabetic foot ulcers.Surveys regarding pain and quality of life will be completed at each study visit.', 'interventionNames': ['Device: Transforming Powder Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Dressing', 'description': 'Half of the subjects will be randomized to receive standard of care wound dressings to treat their diabetic foot ulcers. Wounds will be evaluated weekly, debrided if needed, photographed, and measured. A wound dressing will be applied using standard of care wound products, and the wound will be offloaded when necessary (pressure taken off of the wound using a total contact cast or other device). Wound healing progress will be monitored and compared to transforming powder dressings used to treat diabetic foot ulcers. Surveys regarding pain and quality of life will be completed at each study visit.', 'interventionNames': ['Other: Standard of care topical wound agents and dressings']}], 'interventions': [{'name': 'Transforming Powder Dressing', 'type': 'DEVICE', 'otherNames': ['Altrazeal'], 'description': 'Altrazeal transforming powder dressing is methacrylate-based powder dressing made from the same materials used in the production of contact lenses. Upon hydration, the powder transforms into a moist, non-occlusive barrier that covers and protects the wound from exogenous bacteria while helping manage exudate through vapor transpiration.', 'armGroupLabels': ['Transforming Powder Dressing']}, {'name': 'Standard of care topical wound agents and dressings', 'type': 'OTHER', 'description': 'Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.', 'armGroupLabels': ['Standard of Care Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Medical Group Foot & Ankle at Winter Park', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '21201-1524', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'VA Maryland Health Care System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21230', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Good Samaritan Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21237', 'city': 'Rossville', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Franklin Square', 'geoPoint': {'lat': 39.33844, 'lon': -76.47968}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health Wound Healing Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10462', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Foot Care', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10468-3904', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J. Peters VA Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '12590', 'city': 'Wappingers Falls', 'state': 'New York', 'country': 'United States', 'facility': 'VA Hudson Valley HealthCare System', 'geoPoint': {'lat': 41.59648, 'lon': -73.91097}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Dallas Veteran's Administration Medical Center", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lawrence Lavery, DPM, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altrazeal Life Sciences Inc.'}, {'name': 'Jonathan Saxe, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Altrazeal Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ULURU Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Naval Medical Research Center', 'class': 'FED'}, {'name': 'Military Technology Enterprise Consortium (US)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}