Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Transforming Powder Dressing
* Other: Standard of care topical wound agents and dressings


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transforming Powder Dressing<br>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. | Device: Transforming Powder Dressing<br>* 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.<br>* Other names: Altrazeal;|
| Active Comparator: Standard of Care Dressing<br>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. | Other: Standard of care topical wound agents and dressings<br>* Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of wound closure | Compare rate of complete wound healing in diabetic foot wounds between the two study groups | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Adverse Events | Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections | 12 weeks | 
| 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 | 
| 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 | 
| 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 | 
| Clinician Acceptability | Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Standard of Care Wound Dressings, Transforming Powder Dressing, Diabetic Foot Ulcers, Altrazeal