Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.

Official Title
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Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcer

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Restrata®
* Device: Wound Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years old Patient is willing and capable of complying with all protocol requirements Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) Ulcer must be located at least in part on the foot or ankle Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product Wound size must be < 30cm2 on the day of randomization and initial application of the study product, after initial debridement Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization: Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7 Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg Exclusion Criteria: Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint Patient is pregnant, breast feeding or planning to become pregnant Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS) Patient has a life expectancy less than six months as assessed by the investigator Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period Patient has an additional wound within 3 cm of the study wound Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes Patient not in reasonable metabolic control in the judgment of the investigator Patient with a known history of poor compliance with medical treatments Patient currently undergoing cancer treatment Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone. Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound Study ulcer spontaneously closes during the 2-week run in period

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Synthetic Hybrid-Scale Fiber Matrix<br>Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment. | Device: Restrata®<br>* Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.<br>* Other names: Synthetic Hybrid-Scale Fiber Matrix;|
| Active Comparator: Treatment with Standard of Care<br>Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily. | Device: Wound Dressing<br>* Alginate or Foam wound dressing is intended to manage wounds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 100% Re-epithelialization | Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wound Area | The difference in wound area from baseline to 100% re-epithelialization or week 12 will be summarized for each treatment group in each arm. Wound sizes were documented by the investigator at baseline to end of the treatment period for each participant. | 12 weeks | 
| Time to Wound Closure | The number of weeks from initial application of study treatment until complete re-epithelialization is first identified. | Up to 12 Weeks | 
| Number of Treatment Applications | The number of study treatment applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Synthetic Hybrid-Scale Fiber Matrix, Diabetic Foot Ulcer, Epithelialization