Diabetic Foot Ulcer Clinical Trial
Official title:
Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
Verified date | June 2023 |
Source | ULURU Inc. |
Contact | Vaidehi Shah, MBA |
Phone | 646-431-9455 |
vshah[@]altrazeal.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - 18-89 years old - Diagnosed with diabetes Mellitus; hemoglobin A1C < 12% - Diabetic foot ulcer present for minimum 30 days (Wagner grade 1 or 2 classification) - Wound drainage is minimal or moderate - No clinically active wound infection - Able and willing to provide consent - Has not participated in another research trial within 3 months of enrollment. Exclusion Criteria: - Unable to keep weekly research appointments - Unable or unwilling to use offloading device if recommended - Wounds with large amount (high) drainage - Active gangrene - Wounds impending surgical intervention (including revascularization or plastic surgery) - Untreated osteomyelitis - Soft tissue infection (can be enrolled once infection is cleared) - Active Charcot arthropathy - BMI >45kg/m2 - History of AIDS - History of organ transplant or impending transplant - End stage renal disease requiring dialysis - Decompensated hepatic or cardiac disease - Select autoimmune diseases - Lymphedema - Oral steroid use in last 3 months - Venous stasis disease - Active malignancy (cancer) - Unable to sign consent - Active alcohol or substance abuse - Pregnant or lactating women - Insufficient vascular flow to heal a wound - Hemoglobin A1C >12% |
Country | Name | City | State |
---|---|---|---|
United States | MedStar Good Samaritan Hospital | Baltimore | Maryland |
United States | VA Maryland Health Care System | Baltimore | Maryland |
United States | Bronx Foot Care | Bronx | New York |
United States | James J. Peters VA Medical Center | Bronx | New York |
United States | Dallas Veteran's Administration Medical Center | Dallas | Texas |
United States | Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390 | Houston | Texas |
United States | Northwell Health Wound Healing Center | Lake Success | New York |
United States | MedStar Franklin Square | Rossville | Maryland |
United States | VA Hudson Valley HealthCare System | Wappingers Falls | New York |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | AdventHealth Medical Group Foot & Ankle at Winter Park | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
ULURU Inc. | Military Technology Enterprise Consortium (US), Naval Medical Research Center |
United States,
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. — View 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. — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of wound closure | Compare rate of complete wound healing in diabetic foot wounds between the two study groups | 12 weeks | |
Secondary | Wound healing trajectories and time to wound closure | Evaluate differences in wound healing trajectories and time to wound closure between the two study groups | 12 weeks | |
Secondary | Adverse Events | Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections | 12 weeks | |
Secondary | Subject Satisfaction | 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). | 12 weeks | |
Secondary | Wound pain | 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. | 12 weeks | |
Secondary | Quality of Life while living with a wound | 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) | 12 weeks | |
Secondary | Clinician Acceptability | Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale) | 12 weeks |
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