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

April 3, 2024 updated by: Matthew M. Melin, Mayo Clinic

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

The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vascular Research Team
  • Phone Number: (507) 538-7425

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
        • Contact:
        • Contact:
          • Vascular Research Team
          • Phone Number: 507-538-7425
        • Principal Investigator:
          • Matthew Melin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 years
  • Male and female
  • Transtibial amputation expected.
  • Peripheral arterial disease, Ankle Brachial Index (ABI) and Transcutaneous partial pressure of oxygen (TCP02, if performed)
  • Diabetes
  • Tobacco use at any time in past or current use (pack years)
  • On dialysis (hemodialysis and peritoneal)
  • Prior contralateral leg amputation
  • Ability of subject to give appropriate consent or have an appropriate representative available to do so.

Exclusion Criteria:

  • TcPO2 < 20 (Transcutaneous Cutaneous Partial pressure of oxygen)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fuzzy Wale Compression Stockinet
Subjects with peripheral arterial disease requiring transtibial amputation will have Fuzzy Wale Compression Stockinet applied 3-7 days pre-operatively and utilized for 4-8 weeks post operatively or until prosthetic fitting and wound has achieved full durable healing.
Device: 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 Names:
  • EdemaWear
No Intervention: Standard of care
Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: 8 weeks post-operatively
Number of subject presenting with surgical site infections following transtibial amputation.
8 weeks post-operatively
Wound dehiscence
Time Frame: 8 weeks post-operatively
Number of subject presenting with wound dehiscence following transtibial amputation.
8 weeks post-operatively
Days on negative pressure wound therapy
Time Frame: 8 weeks post-operatively
Number of days that subjects required negative pressure wound therapy
8 weeks post-operatively
Pain control
Time Frame: 8 weeks post-operatively
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
Time Frame: 8 weeks post-operatively
Number of days from transtibial amputation to prosthetic fitting.
8 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 8 weeks post-operatively
Number of days from transtibial amputation to hospital discharge.
8 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Matthew Melin, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-010717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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