A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers
Brief SummaryThe 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 DescriptionThis 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.
Inclusion and Exclusion Criteria
- 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
- University of Southern California, Los Angeles, California, 90033
- Kansas City Vascular, North Kansas City, Missouri, 64116
- St. Anthony's Medical Center, St. Louis, Missouri, 63128
- University of Tennessee, Memphis, Tennessee, 38103
- Essential Institute of Rural Health, Duluth, Minnesota, 55805
- Foot & Andle Center of Mooresville, Mooresville, Indiana, 46158
- American Health Network, Carmel, Indiana, 46032