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

November 4, 2015 updated by: TRx Wound Care Limited

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012-1892
        • Recruiting
        • Carl T. Hayden Medical Research Foundation
        • Contact:
          • Robert Frykberg
          • Phone Number: 602-277-5551
      • Phoenix, Arizona, United States, 85015
        • Recruiting
        • Associated Foot & Ankle Specialists
        • Contact:
          • Arthur Tallis, DPM
          • Phone Number: 602-274-4100
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital
        • Contact:
          • Robert Kirsner
          • Phone Number: 305-243-6191
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
          • Ernest Chiu, MD
          • Phone Number: 212-263-4355
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
          • Howard Kashefsky
          • Phone Number: 919-966-2898
    • Texas
      • Dallas, Texas, United States, 75390-8560
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Javier LaFontaine, DPM
          • Phone Number: 214-648-2132
      • McAllen, Texas, United States, 78501
        • Recruiting
        • Futuro Clinical Trials, LLC
        • Contact:
          • Joseph Caporusso, DPM
          • Phone Number: 956-971-9107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DermaPure™
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™
A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)
Sham Comparator: Standard care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of wound closure
Time Frame: 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".
12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of wound healing in crossover arm
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRx Wound Care Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRG-H01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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