Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease
NCT ID: NCT06308562
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Fuzzy Wale Compression Stockinet
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.
Fuzzy Wale Compression Stockinet
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.
Standard of care
Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet.
No interventions assigned to this group
Interventions
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Fuzzy Wale Compression Stockinet
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female
* Transtibial amputation expected.
* Peripheral arterial disease and Transcutaneous partial pressure of oxygen (TCP02, if performed)
* Ability of subject to give appropriate consent or have an appropriate representative available to do so.
Exclusion Criteria
* Terminal illness or current cancer therapy with chemotherapy
* Inability to undergo ongoing care in Rochester.
* Lack of cognitive ability to follow instructions or monitor residual limb.
* Vulnerable study population
* Pregnancy
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Matthew M. Melin
Principal Investigator
Principal Investigators
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Matthew Melin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Vascular Research Team
Role: primary
Other Identifiers
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23-010717
Identifier Type: -
Identifier Source: org_study_id
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