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NCT03900845 · ClinicalTrials.gov registry record · NA
Adherence and Perspiration While Wearing Lower Limb Prostheses
A NA study, sponsored by Seattle Institute for Biomedical and Clinical Research.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03900845 is a NA study that has completed, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 20 participants.
The verdict
NCT03900845, a NA study, has completed, sponsored by Seattle Institute for Biomedical and Clinical Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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
Interventions
- DEVICE Dynamic Air Exchange - Rising Edge Design (DAE-RED)
- DEVICE Perforated elastomeric liner
- DEVICE As-prescribed prosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-02-17 |
| Est. Completion | 2022-06-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03900845
The ClinicalTrials.gov registry entry for NCT03900845 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dynamic Air Exchange - Rising Edge Design (DAE-RED) is the first listed.
NCT03900845 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03900845 about?
NCT03900845 is a clinical study titled "Adherence and Perspiration While Wearing Lower Limb Prostheses". 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 su...
What is the current status of trial NCT03900845?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2019-02-17. Estimated completion is 2022-06-28.
What interventions are being tested in trial NCT03900845?
The interventions under investigation include: Dynamic Air Exchange - Rising Edge Design (DAE-RED) (DEVICE), Perforated elastomeric liner (DEVICE), As-prescribed prosthesis (DEVICE).
Who is sponsoring clinical trial NCT03900845?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.
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