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

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ClinicalTrials.gov Identifier: NCT02081352
Recruitment Status : Unknown
Verified November 2015 by TRx Wound Care Limited.
Recruitment status was:  Recruiting
First Posted : March 7, 2014
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Other: DermaPure™ Other: Standard care Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : August 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. Rate of wound healing [ Time Frame: 12 weeks ]
    Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline.

  2. Quality of wound healing [ Time Frame: 4 weeks ]
    Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline


Other Outcome Measures:
  1. 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).



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081352


Contacts
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Contact: sheila nicholson +44 3304303066 s.nicholson@tissueregenix.com

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

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Responsible Party: TRx Wound Care Limited
ClinicalTrials.gov Identifier: NCT02081352     History of Changes
Other Study ID Numbers: TRG-H01-01
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015
Keywords provided by TRx Wound Care Limited:
Dermis
Diabetic foot ulcers
Skin substitutes
Decellularized
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases