Fuzzy Wale Compression Stockinet for Peripheral Arterial Disease

Overseen By Vascular Research Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy

Disqualifiers: Allergies, Terminal illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new type of compression stocking, called Fuzzy Wale, can speed healing and reduce costs after a below-the-knee leg amputation. It compares this new treatment to regular compression stockings. Potential participants include those with peripheral arterial disease, a condition where narrowed arteries reduce blood flow to the limbs, who are scheduled for a below-the-knee amputation. Participants will use either the Fuzzy Wale stockings or the standard ones to determine which is more effective. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery and lower costs for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Fuzzy Wale Compression Stockinet is safe for use in transtibial amputation patients?

Research has shown that Fuzzy Wale Compression Stockinet is likely safe for people with peripheral arterial disease. One study found this type of compression safe for those with blocked arteries, known as arterial occlusive disease. Participants in that study experienced healing with this compression method. These findings suggest the treatment is well-tolerated. The available data reported no serious side effects, offering some reassurance about safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fuzzy Wale Compression Stockinet is unique because it offers a new approach to aiding recovery after transtibial amputation in patients with peripheral arterial disease. Unlike the standard compression stockinet used today, this innovative stockinet is designed to be used for 4-8 weeks post-surgery or until prosthetic fitting, aiming to support full and durable wound healing. Researchers are excited about its potential to improve healing outcomes and enhance comfort during the critical recovery phase, potentially leading to quicker and more effective rehabilitations.

What evidence suggests that the Fuzzy Wale Compression Stockinet is effective for peripheral arterial disease?

This trial will compare the Fuzzy Wale Compression Stockinet with standard care for patients with peripheral arterial disease requiring transtibial amputation. Research has shown that the Fuzzy Wale Compression Stockinet may aid healing after below-the-knee amputation. In past cases, patients using this stockinet experienced noticeable healing improvements in about 8 weeks. The stockinet gently compresses the leg, which can enhance blood flow and accelerate healing. Although more research is needed, early results are promising for individuals with poor blood circulation. This treatment could reduce healing time and lower costs. ^{2 3 4 5 6}

Who Is on the Research Team?

Matthew Melin, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who have had a below-the-knee amputation due to peripheral arterial disease. The study aims to include those who require post-surgical healing support.

Inclusion Criteria

I have diabetes.

Tobacco use at any time in past or current use (pack years)

Prior contralateral leg amputation

Exclusion Criteria

Vulnerable study population

Known allergies to any of the components of the compression

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative

Fuzzy Wale Compression Stockinet applied 3-7 days pre-operatively

1 week

Post-operative Treatment

Fuzzy Wale Compression Stockinet utilized for 4-8 weeks post-operatively or until prosthetic fitting and wound has achieved full durable healing

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fuzzy Wale Compression Stockinet

Trial Overview

The trial is testing the effectiveness of a Fuzzy Wale Compression Stockinet in speeding up healing and reducing costs compared to standard compression stockings after transtibial amputation.

How Is the Trial Designed?

Group I: Fuzzy Wale Compression Stockinet Experimental Treatment 1 Intervention

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 II: Standard of care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 375 procedures involving 345 patients with peripheral arterial disease, the greatest improvement in calculated quality of life (cQOL) was observed in patients who underwent endovascular or open revascularization compared to those who had primary amputation or medical therapy.

Patients whose actual treatment matched the surgeon's recommendations or predictions from decision analysis models experienced significantly better outcomes, highlighting the importance of treatment concordance for improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of patients with peripheral arterial disease to accept the recommended treatment results in worse outcomes. Brothers, TE.[2022]

Citations

1.

withpower.com

withpower.com/trial/phase-peripheral-arterial-disease-2-2024-26c83

Fuzzy Wale Compression Stockinet for Peripheral Arterial ...

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 ...

2.

mayo.edu

mayo.edu/research/clinical-trials/cls-20571743

Fuzzy Wale Compression Stockinet to Promote Healing ...

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 ...

3.

policylab.us

policylab.us/clinical-trials/l/conditions/peripheral-arterial-disease

Peripheral Arterial Disease Clinical Trials - Policy Lab

The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for ...

4.

edemawear.com

edemawear.com/wp-content/uploads/2015/06/PosterFour-Layer-VLU-Compression-Dressing-Appears-Safe-for-Profound-Arterial-Ischemia.pdf

Appears Safe for Profound Arterial Ischemia

• Fuzzy wale elastic compression stockinet*. Observe dramatic improvement, after ~8 weeks of elastic compression, and bilateral faux shearling sheep skin in ...

5.

withpower.com

withpower.com/clinical-trials/for-peripheral-arterial-disease?page=2

Top Peripheral Arterial Disease Clinical Trials | Power

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 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06308562

Fuzzy Wale Compression Stockinet to Promote Healing ...

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 ...