Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Matthew Melin, M.D.
CONTACT
Matthew Melin, M.D.
PRINCIPAL_INVESTIGATOR
Vascular Research Team
CONTACT
Recruiting
NCT Number: NCT06308562
Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Fuzzy Wale Compression Stockinet
DeviceEdemaWear 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 (lymphedema, chronic venous insufficiency, congestive heart failure), and optimizing wound healing. The stockinette is often combined with other boxed compression sets. The manufacturer's stated dosage of EdemaWear is 8-12mmHg when used alone.
Other names: EdemaWear
Primary outcomes
-
Surgical site infection
Time frame: 8 weeks post-operatively
Number of subject presenting with surgical site infections following transtibial amputation.
-
Wound dehiscence
Time frame: 8 weeks post-operatively
Number of subject presenting with wound dehiscence following transtibial amputation.
-
Pain control
Time frame: 8 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 fitting
Time frame: 8 weeks post-operatively
Number of days from transtibial amputation to prosthetic fitting.
Secondary outcomes
-
Length of hospital stay
Time frame: 8 weeks post-operatively
Number of days from transtibial amputation to hospital discharge.
Study contacts
Contact information is provided by the study sponsor or research team.
Matthew Melin, M.D.
CONTACT
Vascular Research Team
CONTACT
Sponsors and collaborators
Lead sponsor
Mayo Clinic
Other
Registry information
Official study title
A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 13, 2024
- Registry last updated
- Jan 14, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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