A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Integra LifeSciences Corporation30 enrolled

Overview

The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Foot Ulcer, Diabetic

Interventions

PriMatrixDEVICE

Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy

Standard of CareOTHER

Following sharp debridement, moist wound therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women ≥ 18 years of age and able to give their own consent * Type I or Type II diabetes with investigator-confirmed reasonable metabolic control * Study ulcer has a Wagner grade of 1 or 2 * Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement * A full thickness diabetic foot ulcer located on the foot or ankle * An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening. Exclusion Criteria: * Suspected or confirmed signs/symptoms of wound infection * Wounds with exposed bone or tendon * Hypersensitivity to bovine collagen

Locations (8)

HyperbaRXs

Cumming, Georgia, United States

Covenant Medical Center

Saginaw, Michigan, United States

Caribbean Clinical Trials

San Juan, PR, Puerto Rico

Professional Hospital

Guaynabo, Puerto Rico

Outcomes

Primary Outcomes

Percent of study ulcers healed

Percent of study ulcers healed at week 12 post-randomization

Time frame: 12 weeks post-randomization

Secondary Outcomes

Cost of Treatment

Time frame: 12 weeks

Data from ClinicalTrials.gov

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