Comparing a new powder dressing to standard care for diabetic foot ulcers
Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
This study is testing a new powder dressing to see if it helps heal diabetic foot ulcers better than the usual care for people aged 18 to 89.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | ULURU Inc. Industry-sponsored |
| Locations | 12 sites (Washington, District of Columbia and 11 other locations) |
| Trial ID | NCT05046158 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a transforming powder dressing compared to standard wound care in healing diabetic foot ulcers. Participants aged 18-89 with diabetic foot ulcers present for at least 30 days will be randomly assigned to receive either the new dressing or standard care. The study will involve weekly visits for up to 12 weeks to monitor healing progress. The goal is to determine if the transforming powder dressing can improve healing outcomes for patients with diabetic foot ulcers.
Who should consider this trial
Good fit: Ideal candidates are diabetic men and women aged 18-89 with a diabetic foot ulcer present for a minimum of 30 days.
Not a fit: Patients with severe complications such as active gangrene or untreated osteomyelitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing rates for patients with diabetic foot ulcers.
How similar studies have performed: Other studies have shown promising results with innovative wound care approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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%
Where this trial is running
Washington, District of Columbia and 11 other locations
- MedStar Georgetown University Hospital — Washington, District of Columbia, United States (Recruiting)
- MedStar Washington Hospital Center — Washington, District of Columbia, United States (Recruiting)
- AdventHealth Medical Group Foot & Ankle at Winter Park — Winter Park, Florida, United States (Completed)
- VA Maryland Health Care System — Baltimore, Maryland, United States (Active_not_recruiting)
- MedStar Good Samaritan Hospital — Baltimore, Maryland, United States (Recruiting)
- MedStar Franklin Square — Rossville, Maryland, United States (Recruiting)
- Bronx Foot Care — Bronx, New York, United States (Recruiting)
- James J. Peters VA Medical Center — Bronx, New York, United States (Recruiting)
- Northwell Health Wound Healing Center — Lake Success, New York, United States (Recruiting)
- VA Hudson Valley HealthCare System — Wappingers Falls, New York, United States (Not_yet_recruiting)
- Dallas Veteran's Administration Medical Center — Dallas, Texas, United States (Recruiting)
- Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390 — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Lawrence Lavery, DPM, MPH — Altrazeal Life Sciences Inc.
- Study coordinator: Vaidehi Shah, MBA
- Email: vshah@altrazeal.com
- Phone: 646-431-9455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.