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

Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Age Range:19 - Any
Start Date:August 2014
End Date:February 2017
Contact:sheila nicholson
Phone:+44 3304303066

Use our guide to learn which trials are right for you!

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.

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.

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

- 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

- More than 2 weeks treatment with immunosuppressive agents within 3 months of

- Evidence of malnutrition as confirmed by serum pre-albumin level at screening.

- Evidence of drug or alcohol abuse,
We found this trial at
McAllen, Texas 78501
Phone: 956-971-9107
McAllen, TX
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-2898
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
Chapel Hill, NC
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-2132
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
Dallas, TX
Click here to add this to my saved trials
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Phone: 305-243-6191
University of Miami Hospital The University of Miami changed the face of modern health care...
Miami, FL
Click here to add this to my saved trials
New York, New York 10016
Phone: 212-263-4355
New York, NY
Click here to add this to my saved trials
Phoenix, Arizona 85012
Phone: 602-277-5551
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85015
Phone: 602-274-4100
Phoenix, AZ
Click here to add this to my saved trials