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The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing, a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in humans with venous stasis ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 | No Intervention | ||
| 1 | Experimental | Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase. |
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| 2 | Experimental | Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. |
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| 3 | Experimental | Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taliderm wound healing dressing | Other | Taliderm wound healing dressing will be applied to the wound site as follows depending on assignment to group: Control group receives no intervention. Experimental Group 1 (n = 10) will receive TalidermR only one time at the beginning of the treatment phase. Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase. |
| Measure | Description | Time Frame |
|---|---|---|
| wound healing | 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa J Kelechi, PhD, RN | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roper St. Francis Hospitals | Charleston | South Carolina | 29401 | United States |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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|
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |