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

NCT ID: NCT06308562

Last Updated: 2026-01-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Fuzzy Wale Compression Stockinet

Intervention Type 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.

Standard of care

Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet.

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

Other Intervention Names

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EdemaWear

Eligibility Criteria

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Inclusion Criteria

* \>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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Matthew M. Melin

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vascular Research Team

Role: CONTACT

(507) 538-7425

Matthew Melin, M.D.

Role: CONTACT

(507) 266-6717

Facility Contacts

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Vascular Research Team

Role: primary

(507) 538-7425

Matthew Melin, M.D.

Role: backup

(507) 266-6717

Other Identifiers

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23-010717

Identifier Type: -

Identifier Source: org_study_id

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