Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT05046158
• Lead Sponsor: ULURU Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2021-08-16
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of wound closure	12 weeks	Compare rate of complete wound healing in diabetic foot wounds between the two study groups

Secondary Outcome Measures

Name	Time	Method
Adverse Events	12 weeks	Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
Clinician Acceptability	12 weeks	Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)
Quality of Life while living with a wound	12 weeks	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)
Subject Satisfaction	12 weeks	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).
Wound pain	12 weeks	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.
Wound healing trajectories and time to wound closure	12 weeks	Evaluate differences in wound healing trajectories and time to wound closure between the two study groups

Trial Locations

Locations (12)

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, 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

Bronx Foot Care; 🇺🇸 Bronx, New York, United States

James J. Peters VA Medical Center; 🇺🇸 Bronx, New York, United States

Northwell Health Wound Healing Center; 🇺🇸 Lake Success, New York, United States

VA Hudson Valley HealthCare System; 🇺🇸 Wappingers Falls, New York, United States

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