Fuzzy Wale compression stockinet to promote healing after a below-knee (transtibial) amputation
Official title: A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease
Run by Mayo Clinic · NCT06308562 · Data updated 2026-11-12
This will test whether a Fuzzy Wale compression stockinet helps adults with peripheral arterial disease heal faster after a below-knee amputation compared with the usual compression stocking.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | July 7, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT06308562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with peripheral arterial disease who are scheduled for a transtibial amputation, can provide consent and attend follow-up care at the Mayo Clinic in Rochester, and have no allergy to the stockinet materials are ideal candidates.
✕Probably not a fit
Patients with terminal illness, current chemotherapy, pregnancy, cognitive impairment preventing follow-up, inability to receive ongoing care in Rochester, or known allergy to the compression materials are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional comparison tests a Fuzzy Wale compression stockinet against standard compression care in adults with peripheral arterial disease undergoing transtibial (below-knee) amputation. Participants who meet eligibility will be fitted with the assigned stockinet and followed for time to wound healing and related healthcare costs. Key inclusion criteria include age over 18, diagnosis of peripheral arterial disease, planned transtibial amputation, and ability to consent and receive follow-up care in Rochester; exclusions include known allergy to the device, active chemotherapy, pregnancy, or cognitive inability to follow instructions. The trial is conducted at the Mayo Clinic in Rochester and measures clinical healing outcomes and resource use.
Why it matters
Potential benefit: If successful, this device could shorten time to wound healing and lower post-amputation care costs for patients.
How similar studies have gone: Compression garments are commonly used after amputation and some prior work supports compression to aid healing and limb shaping, but the specific Fuzzy Wale stockinet appears to be a novel device with limited published data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Matthew Melin, M.D. — Mayo Clinic
- Study coordinator: Vascular Research Team
- Email: Melin.Matthew@mayo.edu
- Phone: (507) 538-7425
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.