DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

Study Overview
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Brief Summary
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This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.

Detailed Description
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This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification 3 and 4). A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic for up to 16 weeks. The specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. The time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM) and safety data will be collected.

Official Title
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A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

Conditions
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Lower Extremity Wound, Diabetic Foot Ulcer

Intervention / Treatment
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* Other: DermACELL AWM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone) target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration) target wound that is not amendable to primary closure target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial adequate perfusion to the extremity laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control) Exclusion Criteria: untreated infection of soft tissue or bone untreated autoimmune connective tissue disorders body mass index (BMI) of ≥ 50 undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication active liver disease (e.g. hepatitis A-G), have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment pregnant enrolled in any other interventional clinical research trial an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DermACELL AWM<br>Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use. | Other: DermACELL AWM<br>* Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM). | Days required for granular bed formation | 112 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of applications of study product required to achieve granulation. |  | 16 Weeks | 
| Percent wound area reduction and percent complete wound closure at 16 Weeks. |  | 16 Weeks | 
| The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation. |  | 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, DFU, Lower Extremity Wound, Skin Substitute