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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 is a NA study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00117793
The ClinicalTrials.gov registry entry for NCT00117793 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 US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Total Surface Bearing Suction Socket is the first listed.
NCT00117793 reports 0 study locations.
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.
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