Prosthetic Suspension Systems for Lower Limb Prosthesis Wearers
Trial Summary
What is the purpose of this trial?
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses. It doesn't take long before the presence of sweat on the residual limb leads to a lack of confidence in the security of their prosthetic suspension. Some circumstances allow the wearer to doff the prosthesis before it falls off, wipe it and the residual limb dry, and then don it again. Another option is to simply reduce the intensity of activities before sweat becomes a problem. However, the Warfighter amputee may not be afforded such accommodations. For these service personnel, inadequate moisture management can significantly limit or inhibit their mobility. The objective of the proposed research is to provide lower limb amputees who work in demanding environments with a prosthesis that remains secure despite profuse residual limb sweating without compromising residual limb health and comfort. The aim of this research is to compare three different, lower limb prosthetic suspension systems and identify which is most effective at maintaining a secure adherence when worn in conditions that result in profuse sweating. The investigators also aim to compare how the three study prostheses effect residual limb skin health and comfort when participants pursue their usual activities in the home, work, and community environments. To achieve these aims, the investigators will to recruit 25 below-knee amputees. Each subject will be asked to be asked to wear: (1) their as-prescribed prosthesis, (2) a prosthesis with a perforated elastomeric liner that allows sweat to flow away from the skin, and (3) a prosthesis that has a battery and body-weight activated pump to flow air between the prosthesis and the residual limb skin, allowing expulsion of any accumulated sweat. Subjects will wear each of these prostheses in the home, work, and community environments for two weeks, after which the investigators will measure their residual limb health and comfort. Subjects will then walk on a treadmill in a room whose climate will be set to Middle East-like conditions: 35 °C (95 °F) and 50% relative humidity. After 30 minutes, the investigators will measure any slippage of their prosthesis relative to their limb and how much sweat is expelled. The investigators hypothesize there will be differences in the amount of slippage, residual limb health, and comfort between the three prostheses.
Research Team
Glenn K Klute, PhD
Principal Investigator
Dept. of Veterans Affairs
Eligibility Criteria
This trial is for individuals with a single below-knee amputation who have been using their prescribed prosthesis for at least six months. They must be able to walk without hand support and use the prosthesis daily for more than four hours. Excluded are those with cognitive or language barriers, high heart disease risk, ill-fitting prostheses that can't be adjusted, current incarceration, pregnancy, skin issues on the limb, or walking impairments due to other conditions.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- As-prescribed prosthesis (Prosthetic Suspension System)
- Dynamic Air Exchange - Rising Edge Design (DAE-RED) (Prosthetic Suspension System)
- Perforated elastomeric liner (Prosthetic Suspension System)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
United States Department of Defense
Collaborator
Pete Hegseth
United States Department of Defense
Chief Executive Officer
Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School
Lisa Hershman
United States Department of Defense
Chief Medical Officer since 2021
MD from Uniformed Services University of the Health Sciences