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NCT05884203 · ClinicalTrials.gov registry record · NA
Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance
A NA study of Lower Extremity Amputation, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05884203 is a NA study of Lower Extremity Amputation that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 25 participants, above the 14-participant average among 3 other Lower Extremity Amputation trials with a reported enrollment target (79% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05884203, a NA study of Lower Extremity Amputation, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural communities far from VA Medical Centers or alternative prosthetic clinics. This research seeks to determine if one of the in-person visits traditionally needed to obtain a well-fitting prosthesis can be performed remotely with the assistance of a helper. The investigators seek to discover if an untrained individual (a helper) can wield inexpensive, easy to use, digital technology to capture the shape of a residual limb to see if it can be used to fabricate a prosthetic socket that fits at least as well as one fabricated by a prosthetist using traditional, hand casting methods in the clinic. The expected result of this research is an evidence-based prosthetic fabrication process that reduces Veteran travel burden while providing a prosthesis that fits at least as well as the current standard-of-care. The upshot is a clear improvement in prosthetic provision for Veterans, particularly for those who live in rural communities. To make this determination, the investigators will perform a between-subject experiment with two specific aims. To determine differences in goodness of fit between the two study sockets, the investigators will use both patient reported outcomes, and measurements of the pressure applied to the distal end of the residual limb. Specific Aim 1: Determine if patient reported outcomes, by subjects wearing a prosthetic socket whose shape was captured with study helper assistance, are at least as good as those reported by subjects wearing a socket whose shape was captured by a prosthetist. The investigators propose to recruit Veterans with a below knee amputation and their study helpers to participate in a human subject experiment. Parti
Conditions Studied
Interventions
- DEVICE Caregiver socket
- DEVICE Prosthetist socket
Study Locations (1)
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05884203
The ClinicalTrials.gov registry entry for NCT05884203 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 14-participant average among 3 other Lower Extremity Amputation trials with a reported enrollment target (79% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lower Extremity Amputation appearing as the primary indexed condition, and to 2 interventions - of which Caregiver socket is the first listed.
NCT05884203 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT05884203 about?
NCT05884203 is a clinical study titled "Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance". When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Vetera...
What is the current status of trial NCT05884203?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2023-07-01. Estimated completion is 2026-09-30.
What conditions does trial NCT05884203 study?
This clinical trial studies the following conditions: Lower Extremity Amputation.
What interventions are being tested in trial NCT05884203?
The interventions under investigation include: Caregiver socket (DEVICE), Prosthetist socket (DEVICE).
Who is sponsoring clinical trial NCT05884203?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05884203 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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