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

Primary Purpose

Diabetic Foot Ulcers

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
DermaPure™
Standard care
Sponsored by
TRx Wound Care Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Dermis, Diabetic foot ulcers, Skin substitutes, Decellularized

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Carl T. Hayden Medical Research FoundationRecruiting
  • Associated Foot & Ankle SpecialistsRecruiting
  • University of Miami HospitalRecruiting
  • NYU Langone Medical CenterRecruiting
  • University of North CarolinaRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Futuro Clinical Trials, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

DermaPure™

Standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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

Full Information

First Posted
March 5, 2014
Last Updated
November 4, 2015
Sponsor
TRx Wound Care Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02081352
Brief Title
A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRx Wound Care Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Dermis, Diabetic foot ulcers, Skin substitutes, Decellularized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DermaPure™
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard care
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DermaPure™
Intervention Description
A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)
Intervention Type
Other
Intervention Name(s)
Standard care
Primary Outcome Measure Information:
Title
Incidence of wound closure
Description
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".
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Rate of wound healing
Description
Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline.
Time Frame
12 weeks
Title
Quality of wound healing
Description
Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Rate of wound healing in crossover arm
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sheila nicholson
Phone
+44 3304303066
Email
s.nicholson@tissueregenix.com
Facility Information:
Facility Name
Carl T. Hayden Medical Research Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012-1892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Frykberg
Phone
602-277-5551
Facility Name
Associated Foot & Ankle Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Tallis, DPM
Phone
602-274-4100
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Kirsner
Phone
305-243-6191
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernest Chiu, MD
Phone
212-263-4355
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Kashefsky
Phone
919-966-2898
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8560
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier LaFontaine, DPM
Phone
214-648-2132
Facility Name
Futuro Clinical Trials, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Caporusso, DPM
Phone
956-971-9107

12. IPD Sharing Statement

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

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