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

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081352
• Other study ID #: TRG-H01-01
• Status: Recruiting
• Phase: Phase 4
• First received: March 5, 2014
• Last updated: November 4, 2015
• Start date: August 2014
• Est. completion date: February 2017

Study information

• Verified date: November 2015
• Source: TRx Wound Care Limited
• Contact: sheila nicholson
• Phone: +44 3304303066
• Email: s.nicholson[@]tissueregenix.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Other:
• DermaPure™
A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)
• Standard care

Locations

Country	Name	City	State
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	University of Miami Hospital	Miami	Florida
United States	NYU Langone Medical Center	New York	New York
United States	Associated Foot & Ankle Specialists	Phoenix	Arizona
United States	Carl T. Hayden Medical Research Foundation	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
TRx Wound Care Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of wound healing in crossover arm	Percentage reduction in ulcer area and volume, weekly up to Week 18 compared to Week 12 for a subset of subjects who receive first application of DermaPure™ at Week 12 (Crossover arm).	6 weeks	No
Primary	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	No
Secondary	Rate of wound healing	Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline.	12 weeks	No
Secondary	Quality of wound healing	Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline	4 weeks	No