RecruitingNot ApplicableNCT06308562

Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease

A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

>18 years
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 Criteria6

Known allergies to any of the components of the compression.
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

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Interventions

DEVICEFuzzy 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.