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| Name | Class |
|---|---|
| Regenesis Biomedical, Inc. | INDUSTRY |
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This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins, usually of the legs) will result in increased rates of healing and a larger proportion of completely healed wounds after 12 weeks of therapy compared to wounds treated identically using a Provant device that is not activated to emit radiofrequency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Active Treatment | Experimental | Provant device activated to emit RF energy |
|
| 2 - Inactive Treatment | Sham Comparator | Provant device not activated to emit RF energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provant Device (Wound Therapy System) | Device | Twice daily application of the active Provant device to the wound for twelve (12) weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of wound closure (measured as change in surface area - mm2/day) | during and after 12 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of wounds achieving complete healing | afer 12 weeks of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Gordon, M.D., Ph.D. | VA Long Beach Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach Healthcare System | Long Beach | California | 90822-5201 | United States | ||
| VA Greater Los Angeles Healthcare System |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Provant Device - Inactive | Device | Twice daily application of the inactive Provant device to the wound for twelve (12) weeks. |
|
| Los Angeles |
| California |
| 90073 |
| United States |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |