Peripheral Arterial Disease
Conditions
Brief summary
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
DEVICEFuzzy 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 (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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Time to prosthetic fitting | 8 weeks post-operatively | Number of days from transtibial amputation to prosthetic fitting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 8 weeks post-operatively | Number of days from transtibial amputation to hospital discharge. |
Countries
United States
Contacts
Primary ContactVascular Research Team
Backup ContactMatthew Melin, M.D.
Outcome results
None listed