A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers

Study Overview
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Brief Summary
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This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.

Detailed Description
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DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to hard to heal chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.

Official Title
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Phase IV Prospective, Multi-Center, Randomized, Single-Blind, Active and Standard Care-Controlled Study of DermaPure™ in Patients With Hard to Heal Chronic, Neuropathic Diabetic Foot Ulcers With Crossover Design for Standard Care Arm

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Other: DermaPure™
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or Type 2 diabetes with HbA1c ≤12% Adequate perfusion A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification. Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period. Exclusion Criteria: BMI greater than 45kg/m2. Presence of infection Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement. A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient. Therapy with any investigational agent or drug within 4 weeks preceding the screening visit. More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment. Evidence of malnutrition as confirmed by serum pre-albumin level at screening. Evidence of drug or alcohol abuse,

Ages Eligible for Study
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Minimum Age: 19 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: DermaPure™<br>DermaPure™ in combination with standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear. | Other: DermaPure™<br>* A minimally manipulated human tissue regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps)<br>|
| Sham Comparator: Standard care<br>Standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear. | Other: Standard care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of wound closure | The incidence of full wound closure at or before 12 weeks, where full wound closure is defined as 100% re-epithelialization, without drainage, that has been confirmed at two study visits up to 14 days apart. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of wound healing | Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline. | 12 weeks | 
| Quality of wound healing | Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermis, Diabetic foot ulcers, Skin substitutes, Decellularized