Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix

Integra LifeSciences Corporation92 enrolled

Overview

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Foot Ulcer, Diabetic

Interventions

PriMatrix Moist Wound TherapyDEVICE

sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading

Standard of Care Moist Wound TherapyOTHER

sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type I or Type II diabetes * A diabetic foot ulcer located on the foot or ankle at least one square centimeter Exclusion Criteria: * Suspected or confirmed signs/symptoms of wound infection * Hypersensitivity to bovine collagen

Locations (18)

University of Southern California

Los Angeles, California, United States

Foot and Ankle Clinic

Los Angeles, California, United States

Outcomes

Primary Outcomes

Complete wound closure

Time frame: by 12 weeks

Secondary Outcomes

Change in predicted medical expenditures between PriMatrix and Standard of Care

Time frame: over 24 weeks

Change in quality of life measurements between PriMatrix and Standard of Care

Time frame: between baseline and 24 weeks

Nonserious and serious adverse events

Time frame: over 24 weeks

Data from ClinicalTrials.gov

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