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No participants enrolled, per PI discretion
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Standard care of care and up to twelve (12) weekly debridements. Subjects randomized into the weekly debridement group will receive up to twelve (12) debridement during the twelve (12) weeks of the study. There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group.
The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.
The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| debridement | Experimental | monthly vs weekly debridement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| debridement | Procedure | There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Wolcott, M.D. | Southwest Regional Wound Care Center | Principal Investigator |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003646 | Debridement |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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