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NCT05287646 · ClinicalTrials.gov registry record · NA
Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
A NA study of Amputation, Lower Limb, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05287646 is a NA study of Amputation, Lower Limb that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 21 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05287646, a NA study of Amputation, Lower Limb, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.
Conditions Studied
Interventions
- DEVICE Suction Suspension First
- DEVICE Elevated Vacuum Suspension First
Study Locations (1)
New York
- VA NY Harbor Healthcare System, New York, NY - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-01-05 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05287646
The ClinicalTrials.gov registry entry for NCT05287646 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 Amputation, Lower Limb appearing as the primary indexed condition, and to 2 interventions - of which Suction Suspension First is the first listed.
NCT05287646 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05287646 about?
NCT05287646 is a clinical study titled "Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray". Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems h...
What is the current status of trial NCT05287646?
This trial is currently recruiting. It is a NA study. The enrollment target is 21 participants. The study started on 2024-01-05. Estimated completion is 2027-03-31.
What conditions does trial NCT05287646 study?
This clinical trial studies the following conditions: Amputation, Lower Limb.
What interventions are being tested in trial NCT05287646?
The interventions under investigation include: Suction Suspension First (DEVICE), Elevated Vacuum Suspension First (DEVICE).
Who is sponsoring clinical trial NCT05287646?
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 NCT05287646 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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