Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | November 2016 |
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
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.
(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.
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 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
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16
sites
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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