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NCT00117793 · ClinicalTrials.gov registry record · NA
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
A NA study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT00117793: Completed NA study, sponsored by US Department of Veterans Affairs.
NCT00117793 is a NA study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00117793, a NA study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system. The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.
Interventions
- DEVICE Total Surface Bearing Suction Socket
- DEVICE Vacuum assisted socket system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-09 |
| Phase | NA |
What the finished NCT00117793 record still lists
NCT00117793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Total Surface Bearing Suction Socket is the first listed.
NCT00117793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00117793 about?
NCT00117793 is a clinical study titled "Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit". The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that...
What is the current status of trial NCT00117793?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2005-08. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00117793?
The interventions under investigation include: Total Surface Bearing Suction Socket (DEVICE), Vacuum assisted socket system (DEVICE).
Who is sponsoring clinical trial NCT00117793?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00117793's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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