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

NCT06308562 | Recruiting FDA Device

• 1 other identifier: 23-010717
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Length of hospital stay

  8 weeks post-operatively

Study Arms (2)

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.

Device: Fuzzy Wale Compression Stockinet

Standard of care

NO INTERVENTION

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

Interventions

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.

Also known as: EdemaWear

Fuzzy Wale Compression Stockinet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Matthew Melin, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vascular Research Team

CONTACT

(507) 538-7425; Melin.Matthew@mayo.edu

Matthew Melin, M.D.

CONTACT

(507) 266-6717; Melin.Matthew@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)