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

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Fuzzy Wale Compression Stockinet

• Registration Number: NCT06308562
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-13
• Status Verified: 2024-07
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Study Start: 2025-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuzzy Wale Compression Stockinet	Fuzzy Wale Compression Stockinet	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.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	8 weeks post-operatively	Number of subject presenting with surgical site infections following transtibial amputation.
Wound dehiscence	8 weeks post-operatively	Number of subject presenting with wound dehiscence following transtibial amputation.
Days on negative pressure wound therapy	8 weeks post-operatively	Number of days that subjects required negative pressure wound therapy
Time to prosthetic fitting	8 weeks post-operatively	Number of days from transtibial amputation to prosthetic fitting.
Pain control	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.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	8 weeks post-operatively	Number of days from transtibial amputation to hospital discharge.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States