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

Phase 4

• Conditions: Diabetic Foot Ulcers

• Registration Number: NCT02081352
• Lead Sponsor: TRx Wound Care Limited

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Study Start: 2014-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05
• Primary Completion: 2016-11
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of wound closure	12 weeks	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".

Secondary Outcome Measures

Name	Time	Method
Rate of wound healing	12 weeks	Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline.
Quality of wound healing	4 weeks	Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline

Trial Locations

Locations (7)

Carl T. Hayden Medical Research Foundation; 🇺🇸 Phoenix, Arizona, United States

Associated Foot & Ankle Specialists; 🇺🇸 Phoenix, Arizona, United States

University of Miami Hospital; 🇺🇸 Miami, Florida, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Futuro Clinical Trials, LLC; 🇺🇸 McAllen, Texas, United States