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The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V.A.C.® Therapy | Active Comparator | Vacuum Assisted Closure device that utilizes controlled negative pressure |
|
| Procellera™ Wound Dressing with V.A.C.® Therapy | Experimental | Procellera wound dressing used as a primary contact layer on the wound bed, used in conjunction with NPWT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procellera™ Wound Dressing with V.A.C.® Therapy | Device | Dressing indicated for partial and full-thickness wounds. Weekly dressing changes, more frequently if needed. Used as a primary contact layer in conjunction with NPWT. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing over time | 3 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald M Guberman, DPM | Wyckoff Heights Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wyckoff Heights Medical Center | Brooklyn | New York | 11237 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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|
| V.A.C.® Therapy | Device | Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week. |
|
|
| 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 |