Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fuzzy Wale Compression Stockinet.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease
Overview
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 amputation patients as compared to standard of care treatment compression stocking.
Interventions
- 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
Primary outcome measures
- Surgical site infection [Time frame: 8 weeks post-operatively]
- Wound dehiscence [Time frame: 8 weeks post-operatively]
- Pain control [Time frame: 8 weeks post-operatively]
- Time to prosthetic fitting [Time frame: 8 weeks post-operatively]
Secondary outcome measures (1)
- Length of hospital stay [Time frame: 8 weeks post-operatively]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06308562 · 23-010717