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

Trial Summary

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.

How does the Fuzzy Wale Compression Stockinet treatment for peripheral arterial disease differ from other treatments?

The Fuzzy Wale Compression Stockinet is unique because it likely uses a specialized compression technique, which may differ from standard compression therapies by providing a more tailored fit or pressure distribution, potentially improving comfort and effectiveness for patients with peripheral arterial disease. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Matthew Melin, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 3-7 days pre-operatively 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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

PredyCLU: A prediction system for chronic leg ulcers based on fuzzy logic; part II-Exploring the arterial side. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Diagnostic utility of the two methods of ankle brachial index in the detection of peripheral arterial disease of lower extremities. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Costs and medical care consequences associated with the diagnosis of peripheral arterial disease. [2018]