Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.

Official Title
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Evaluation of Biovance, a Dehydrated Decellularized Human Amniotic Membrane Allograft, in Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Other: Biovance®
* Other: Standard of Care, Diabetic Foot Ulcers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has: been diagnosed with Diabetes Mellitus (insulin or non-insulin dependent) and peripheral neuropathy (loss of protective sensation) in affected foot a HbA1c of less than 10% assessed within last 12 weeks a full-thickness diabetic neuropathic foot ulcer that is free from tunnels/sinus tracks, necrotic tissue, exposed bone and/or tendon, and osteomyelitis post debridement (Wagner 1 or 2; Appendix I) one (target) diabetic neuropathic foot ulcer of less than 12 months duration that has an area that measures ≥ 1.5 and ≤ 10 cm2 post debridement (max length x max width) at screening that is on any surface and part of the foot (fore-, mid- or hind-foot) with an etiology related to loss of protective sensation in that foot. a target ulcer that closed <30% during the 2 week run-in period (2 weeks management with SOC following signature of informed consent prior to potential randomization) sufficient arterial supply to affected foot tested within the past 60 days Exclusion Criteria: The subject has: ulcers of non-diabetic etiology on the study foot a target ulcer clinically infected or has underlying osteomyelitis at time of study treatment initiation clinical evidence of gangrene on any part of the affected foot a target ulcer with exposed bone or tendon any malignancy or a neoplasm at the target ulcer site active Charcot Foot or Charcot Foot that is unable to be offloaded (stable, non-active Charcot deformity that is able to be offloaded is acceptable) more than 3 ulcers on the study foot, including the target ulcer, and all other ulcers must be at least 3 cm removed from the target ulcer any significant comorbid disease that may interfere with wound healing received chemotherapy, radiotherapy, immunosuppressant or corticosteroid (greater than 10 mg prednisone-equivalent per day) within the past 30 days. had the diabetic foot ulcer treated with an experimental drug/biologic/device, or a live-cell therapy (experimental or marketed), or active moist wound healing therapy within 30 days of randomization day

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 |
| --- | --- |
| Active Comparator: Biovance®<br>Application of Biovance® for up to 12 weeks or until wound closure, whichever is sooner. Non-active moist wound treatment, debridement as needed, off-loading device | Other: Biovance®<br>* Application of Biovance® for up to 12 weeks or until wound closure, whichever is sooner. Non-active moist wound treatment, debridement as needed, off-loading<br>Other: Standard of Care, Diabetic Foot Ulcers<br>* Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner<br>|
| Active Comparator: Standard of Care, Diabetic Foot Ulcers<br>Non-active moist wound treatment, debridement as needed, off-loading device | Other: Standard of Care, Diabetic Foot Ulcers<br>* Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure observed at up to 12 weeks following baseline visit defined as 100% re-epithelialization without drainage confirmed at 2 weeks following initial observation of closure. |  | 12 weeks |