A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Other: DermaPure™ Other: Standard care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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
- 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".
- Rate of wound healing [ Time Frame: 12 weeks ]Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline.
- Quality of wound healing [ Time Frame: 4 weeks ]Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline
- 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).
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
|Contact: sheila nicholson||+44 firstname.lastname@example.org|
|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|