Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)

Study Overview
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Brief Summary
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The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).

Detailed Description
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Control Group: None (Utilize historical / published data on outcomes using standard of care) Test Group: Treatment of DFUs with RestrataTM Wound Matrix Study Type: Interventional Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Official Title
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Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Restrata TM Wound Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18 or older Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA). Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study Patient has adequate control of diabetes, as demonstrated by one of the following within 30 days of screening: HbA1c < 12% Serum Creatinine < 3.0mg/dl Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit: Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR ABIs with results of ≥0.7 and ≤1.5, OR Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Exclusion Criteria: Patients presenting with an ulcer probing to bone (UT Grade IIIA-D) Patients whose index diabetic foot ulcers are greater than 25cm2 Patient has an additional wound within 3cm of the study wound Patients not in reasonable metabolic control Patients with a known history of poor compliance with medical treatments Patients who have been previously enrolled into this study, or are presently participating in a clinical trial with DFU indications Patients with known or suspected local skin malignancy to the index diabetic ulcer Patients diagnosed with autoimmune connective tissues diseases Patients that have received a graft material on the study ulcer within the previous 30 days Patients who are pregnant or breast feeding Patients who are taking medications that are considered immune system modulator Study wound has closed > 30% over the two-week run-in period Patients with a known allergy to resorbable suture materials

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Restrata TM Wound Matrix<br>Prospective, single armed, non-randomized study with direct assignment | Device: Restrata TM Wound Matrix<br>* The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Wound Closed | from baseline at week 0 to 14 weeks | Up to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wound Area From Baseline | Wound area measurements will be made via tracing acetate every week for 14 weeks. | Baseline and weekly for up to 14 weeks | 
| Time to Wound Closure | The number of weeks until complete closure is first identified will be determined for each patient who has been deemed completely closed within the 14 week treatment period. | Baseline up to 14 weeks |