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

Mayo Clinic

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Fuzzy Wale Compression Stockinet

Study type: Interventional

Funder types: Other

Identifiers

NCT06308562

23-010717

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Fuzzy Wale Compression Stockinet

Experimental group

Description:

Subjects with peripheral arterial disease requiring transtibial amputation will have Fuzzy Wale Compression Stockinet applied and utilized for 4-8 weeks post operatively or until prosthetic fitting and wound has achieved full durable healing.

Treatment:

Device: Fuzzy Wale Compression Stockinet

Standard of care

No Intervention group

Description:

Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet.