Clinical trial NCT01858545: A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
Official title: An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Detailed description: Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

Eligibility criteria: Major Inclusion Criteria:

* Subject has a current diagnosis of type I or type II diabetes
* Subject's ulcer is on the forefoot or heel
* Subject has chronic ulcer - has been present for minimum of 4 weeks
* Subject's ulcer extends through the dermis and into the subcutaneous tissue
* Subject's HgbA1c \<12%
* Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Major Exclusion Criteria:

* Subject has a known sensitivity to bovine- or porcine-derived products.
* Subject's ulcer is due to a non-diabetic etiology
* Subject's ulcer is over a Charcot deformity of the mid-foot
* Subject's random blood sugar readings are \>450 mg/dL
* Subject is on dialysis
* Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer

Primary outcomes:
measure: Number of Participants With Complete Wound Closure
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl t. Hayden Phoenix VA Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Associated Foot & Ankle Specialists, PC
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research Inc.
state: California
city: Fresno
country: United States
facility: Valley Vascular Surgery Associates
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Homestead
country: United States
facility: Advanced Research Institute of Miami
state: Florida
city: Miami Beach
country: United States
facility: NewPhase Clinical Trials, Corp.
state: Florida
city: Saint Petersburg
country: United States
facility: Professional Health Care of Pinellas
state: Florida
Study officials:
affiliation: Integra LifeSciences
name: Thomas Gilbert, PhD
role: STUDY_DIRECTOR
References: