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Site selection
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To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).
Healing percentages
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PriMatrix | Experimental | PriMatrix Dermal Repair Scaffold |
|
| PriMatrix Ag | Experimental | PriMatrix Ag Antimicrobial Dermal Repair Scaffold |
|
| Standard of Care | Active Comparator | Standard of Care Moist Wound Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PriMatrix | Device | fetal bovine dermal scaffold |
| |
| PriMatrix Ag |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of VLUs healed by week 12 post-randomization | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of treatment | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Starinski, DPM | TEI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caribbean Clinical Trials | San Juan | PR | 00918 | Puerto Rico | ||
| Dr. Pila Metropolitan Hospital Wound Healing Center |
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| Device |
fetal bovine dermal scaffold with Ag |
|
| moist wound therapy | Procedure | standard of care moist wound therapy |
|
| Ponce |
| 00717 |
| Puerto Rico |
| Doctors' Center Hospital of San Juan | San Juan | 00918 | Puerto Rico |
| Wound and Ulcer Care Clinic of San Juan | San Juan | 00918 | Puerto Rico |
| Wilma N. Vazquez Hospital | Vega Baja | 00694 | Puerto Rico |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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