Clinical trial NCT02081352: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Foot Ulcers
Keywords: Dermis
Diabetic foot ulcers
Skin substitutes
Decellularized
Lead sponsor: TRx Wound Care Limited
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Incidence of wound closure
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of wound healing
timeFrame: 12 weeks
measure: Quality of wound healing
timeFrame: 4 weeks
Other outcomes:
measure: Rate of wound healing in crossover arm
timeFrame: 6 weeks
Locations:
city: Phoenix
country: United States
facility: Carl T. Hayden Medical Research Foundation
state: Arizona
city: Phoenix
country: United States
facility: Associated Foot & Ankle Specialists
state: Arizona
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
Study officials:
References: