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The objective of this study is to determine if using Fuzzy Wale compression stockinet can assist in reducing the healing time and decrease costs in transtibial amputation patients as compared to standard of care treatment compression stocking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuzzy Wale Compression Stockinet | Experimental | Subjects with peripheral arterial disease requiring transtibial amputation will have Fuzzy Wale Compression Stockinet applied and utilized for 4-8 weeks post operatively or until prosthetic fitting and wound has achieved full durable healing. |
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| Standard of care | No Intervention | Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuzzy Wale Compression Stockinet | Device | EdemaWear is a tubular, circular knit elastic stockinet fabricated with elastic, vertically oriented fuzzy wales, with the compression provided by the elastic, horizontal oriented Lycra® spandex yarns knitted in between. The stockinet is applied from the foot to the popliteal crease, over the affected area. EdemaWear can be applied in direct contact with the skin or over a wound care dressing. Sizing is based on leg circumference. EdemaWear is indicated for edema management of various etiologies (lymphedema, chronic venous insufficiency, congestive heart failure), and optimizing wound healing. The stockinette is often combined with other boxed compression sets. The manufacturer's stated dosage of EdemaWear is 8-12mmHg when used alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Number of subject presenting with surgical site infections following transtibial amputation. | 8 weeks post-operatively |
| Wound dehiscence | Number of subject presenting with wound dehiscence following transtibial amputation. | 8 weeks post-operatively |
| Pain control | Pain control during healing following transtibial amputation will be measured using the Visual Analog Scale (VAS). VAS scores range from 0-10 with 10 being the worst possible pain and 0 being no pain. | 8 weeks post-operatively |
| Time to prosthetic fitting | Number of days from transtibial amputation to prosthetic fitting. | 8 weeks post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Number of days from transtibial amputation to hospital discharge. | 8 weeks post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vascular Research Team | Contact | (507) 538-7425 | Melin.Matthew@mayo.edu | |
| Matthew Melin, M.D. | Contact | (507) 266-6717 | Melin.Matthew@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Melin, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |