New technology for managing fluid changes in prosthetic sockets for amputees
NIH Release/Relock Socket
This study is testing a new type of prosthetic socket for lower-limb amputees to see if it can better manage fluid changes and improve comfort and mobility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04305782 on ClinicalTrials.gov |
What this trial studies
This research aims to develop and assess a novel prosthetic socket technology designed to manage fluid volume fluctuations in the residual limb of lower-limb amputees. The technology allows for partial doffing of the socket, which may help improve comfort and mobility by facilitating better fit and reducing skin injuries. Participants will engage in both in-lab and out-of-lab interventions to evaluate the effectiveness of this new approach. The study seeks to enhance understanding of how socket adjustments can aid in fluid recovery and retention.
Who should consider this trial
Good fit: Ideal candidates include individuals with a trans-tibial amputation who regularly use a prosthesis and can walk with it for at least 2 minutes.
Not a fit: Patients currently experiencing skin breakdown or those unable to meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly improve the comfort and mobility of lower-limb amputees by providing a better-fitting prosthetic socket.
How similar studies have performed: While similar approaches to managing prosthetic fit have been explored, this specific technology for partial doffing is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Had trans-tibial amputation at least 18 months prior to enrollment * Regularly wear a definitive prosthesis for at least 7 hours per week * Have a residual limb length of at least 9 cm * K2 or higher MFCL * Able to walk continuously with a prosthesis for at least 2 minutes at a time * Sit, stand, and negotiate a step of 5.0 cm Participants involved remotely will have to meet the following inclusion criteria: * Have a spare prosthesis * No cognitive issues * Good hand dexterity and strength (not frail) * Capable of communication over a video Zoom conference call. Exclusion Criteria: * Current presence of skin breakdown * Unable to satisfy inclusion criteria
Where this trial is running
Seattle, Washington
- University of Washington Bioengineering — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Joan E Sanders, PhD — University of Washington
- Study coordinator: Joan E Sanders, PhD
- Email: jsanders@u.washington.edu
- Phone: 2062215872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.