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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: PriMatrix Moist Wound Therapy
* Other: Standard of Care Moist Wound Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PriMatrix Moist Wound Therapy<br>sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading | Device: PriMatrix Moist Wound Therapy<br>* sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading<br>* Other names: PriMatrix Dermal Repair Scaffold;Other: Standard of Care Moist Wound Therapy<br>* sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading<br>|
| Other: Standard of Care Moist Wound Therapy<br>sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading | Other: Standard of Care Moist Wound Therapy<br>* sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete wound closure |  | by 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in predicted medical expenditures between PriMatrix and Standard of Care |  | over 24 weeks | 
| Change in quality of life measurements between PriMatrix and Standard of Care |  | between baseline and 24 weeks | 
| Nonserious and serious adverse events |  | over 24 weeks |