Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.

Key facts

Study ID

NCT05046158

Run by

ULURU Inc.

People needed

135

Starts

2021-08-16

Expected to finish

2025-11-06

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• AdventHealth Medical Group Foot & Ankle at Winter Park — Winter Park, Florida, United States
• VA Maryland Health Care System — Baltimore, Maryland, United States
• MedStar Good Samaritan Hospital — Baltimore, Maryland, United States
• MedStar Franklin Square — Rossville, Maryland, United States
• Northwell Health Wound Healing Center — Lake Success, New York, United States
• Bronx Foot Care — The Bronx, New York, United States
• James J. Peters VA Medical Center — The Bronx, New York, United States
• VA Hudson Valley HealthCare System — Wappingers Falls, 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

Full record on ClinicalTrials.gov

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