Fuzzy Wale Compression Stockinet for Transtibial Amputation Healing

This study is looking at whether a special type of compression stocking, called EdemaWear (Fuzzy Wale Compression Stockinet), can help people heal faster and reduce costs after a transtibial amputation (removal of the leg below the knee) due to Peripheral Arterial Disease (PAD, a condition where narrowed arteries reduce blood flow to the limbs). Researchers want to see if EdemaWear is better than standard compression stockings. They will measure if participants have fewer surgical site infections, less wound dehiscence (when a wound reopens), and better pain control 8 weeks after surgery. Adults aged 18 and older who are expected to have a transtibial amputation due to PAD can join. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks post-operatively to assess surgical site infection, wound dehiscence, and pain control.

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NCT06308562

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

Recruiting
NAAges 18+InterventionalSupportive care
Mayo Clinic
~40 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:Fuzzy Wale Compression Stockinet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Surgical site infection
Measured over 8 weeks post-operatively
+3 more outcomes measured
Peripheral Arterial Disease
1 sites across 1 states
Minnesota1
  • Matthew Melin, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

\>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

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
  • Surgical site infection8 weeks post-operatively

    Number of subject presenting with surgical site infections following transtibial amputation.

  • Wound dehiscence8 weeks post-operatively

    Number of subject presenting with wound dehiscence following transtibial amputation.

  • Pain control8 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.

  • Time to prosthetic fitting8 weeks post-operatively

    Number of days from transtibial amputation to prosthetic fitting.