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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PriMatrix Moist Wound Therapy | Active Comparator | sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading |
|
| Standard of Care Moist Wound Therapy | Other | sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PriMatrix Moist Wound Therapy | Device | sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete wound closure | by 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Starinski, DPM | TEI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Foot and Ankle Clinic |
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|
| Standard of Care Moist Wound Therapy | Other | sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading |
|
| Nonserious and serious adverse events | over 24 weeks |
| Los Angeles |
| California |
| 90057 |
| United States |
| Advanced Research Institute of Miami | Miami | Florida | 33030 | United States |
| Advanced Foot & Ankle Specialists | Tampa | Florida | 33606 | United States |
| Joseph M. Still Research Foundation | Augusta | Georgia | 30909 | United States |
| American Health Network | Carmel | Indiana | 46032 | United States |
| Foot & Andle Center of Mooresville | Mooresville | Indiana | 46158 | United States |
| Imperial Health | Lake Charles | Louisiana | 70601 | United States |
| Kansas City Vascular | North Kansas City | Missouri | 64116 | United States |
| St. Anthony's Medical Center | St Louis | Missouri | 63128 | United States |
| North Shore Long Island Jewish Comprehensive Wound Healing Center | Lake Success | New York | 11042 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Tennessee | Memphis | Tennessee | 38103 | United States |
| Centro Podiatrico del Norte | Arecibo | 00612 | Puerto Rico |
| Renier Gonzalez-Cruz | Juana Diaz | 00795 | Puerto Rico |
| VA Carribean Healthcare System | San Juan | 00921 | Puerto Rico |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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