Recruiting

DermaPure™

Sponsor:

TRx Wound Care Limited

Code:

NCT02081352

Conditions

Diabetic Foot Ulcers

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

DermaPure™

Standard care

Study Details

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.

Conditions

Diabetic Foot Ulcers

Study ID

NCT02081352

Start date

Aug, 2014

Status verified date

Nov, 2015

Completion date

Feb, 2017

Anticipated

Primary completion date

Nov, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

DermaPure™

A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)

Standard care

Primary outcome measure

  • Incidence of wound closure [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

sheila nicholson

+44 3304303066s.nicholson@tissueregenix.com

Locations

Carl T. Hayden Medical Research Foundation

Recruiting

Phoenix, Arizona, United States, 85012-1892

Contacts

Robert Frykberg

602-277-5551

Associated Foot & Ankle Specialists

Recruiting

Phoenix, Arizona, United States, 85015

Contacts

Arthur Tallis, DPM

602-274-4100

University of Miami Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Robert Kirsner

305-243-6191

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Ernest Chiu, MD

212-263-4355

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Howard Kashefsky

919-966-2898

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-8560

Contacts

Javier LaFontaine, DPM

214-648-2132

Futuro Clinical Trials, LLC

Recruiting

McAllen, Texas, United States, 78501

Contacts

Joseph Caporusso, DPM

956-971-9107

More Information

Sponsor

TRx Wound Care Limited

Last update posted

Nov 5, 2015

Last verified

Nov, 2015

Keywords

  • Dermis
  • Diabetic foot ulcers
  • Skin substitutes
  • Decellularized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TRx Wound Care Limited on 2015-11-05.