Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
- Conditions
- Foot Ulcer, Diabetic
- Interventions
- Other: Standard of Care Moist Wound TherapyDevice: PriMatrix Moist Wound Therapy
- Registration Number
- NCT01729286
- Lead Sponsor
- Integra LifeSciences Corporation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 92
- Type I or Type II diabetes
- A diabetic foot ulcer located on the foot or ankle at least one square centimeter
- Suspected or confirmed signs/symptoms of wound infection
- Hypersensitivity to bovine collagen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Moist Wound Therapy Standard of Care Moist Wound Therapy sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading PriMatrix Moist Wound Therapy Standard of Care Moist Wound Therapy sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading PriMatrix Moist Wound Therapy PriMatrix Moist Wound Therapy sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
- Primary Outcome Measures
Name Time Method Complete wound closure by 12 weeks
- Secondary Outcome Measures
Name Time Method Change in quality of life measurements between PriMatrix and Standard of Care between baseline and 24 weeks Change in predicted medical expenditures between PriMatrix and Standard of Care over 24 weeks Nonserious and serious adverse events over 24 weeks
Trial Locations
- Locations (18)
University of Southern California
🇺🇸Los Angeles, California, United States
Foot and Ankle Clinic
🇺🇸Los Angeles, California, United States
Advanced Research Institute of Miami
🇺🇸Miami, Florida, United States
Joseph M. Still Research Foundation
🇺🇸Augusta, Georgia, United States
American Health Network
🇺🇸Carmel, Indiana, United States
Advanced Foot & Ankle Specialists
🇺🇸Tampa, Florida, United States
Foot & Andle Center of Mooresville
🇺🇸Mooresville, Indiana, United States
Imperial Health
🇺🇸Lake Charles, Louisiana, United States
Kansas City Vascular
🇺🇸North Kansas City, Missouri, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
St. Anthony's Medical Center
🇺🇸St. Louis, Missouri, United States
North Shore Long Island Jewish Comprehensive Wound Healing Center
🇺🇸Lake Success, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Centro Podiatrico del Norte
🇵🇷Arecibo, Puerto Rico
Renier Gonzalez-Cruz
🇵🇷Juana Diaz, Puerto Rico
VA Carribean Healthcare System
🇵🇷San Juan, Puerto Rico
University of Tennessee
🇺🇸Memphis, Tennessee, United States