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NCT00985842 · ClinicalTrials.gov registry record · NA
Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT00985842: Completed NA study, sponsored by VA Office of Research and Development.
NCT00985842 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985842, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.
Primary Outcome
Tissue oxygen saturation (StO2)
Interventions
- DEVICE Pe-Lite and sleeve suspension socket
- DEVICE Total Surface bearing a socket with a sleeve suspension but without suction
- DEVICE Total surface bearing suction socket with a pin lock suspension
- DEVICE Total surface bearing suction socket with a sleeve suspension
- DEVICE Vacuum-assisted socket system (Harmony System, Otto Bock)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-11-01 |
| Est. Completion | 2012-10-26 |
| Phase | NA |
What the finished NCT00985842 record still lists
NCT00985842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 5 interventions - of which Pe-Lite and sleeve suspension socket is the first listed.
NCT00985842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00985842 about?
NCT00985842 is a clinical study titled "Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking". Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesi...
What is the current status of trial NCT00985842?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2009-11-01. Estimated completion is 2012-10-26.
What interventions are being tested in trial NCT00985842?
The interventions under investigation include: Pe-Lite and sleeve suspension socket (DEVICE), Total Surface bearing a socket with a sleeve suspension but without suction (DEVICE), Total surface bearing suction socket with a pin lock suspension (DEVICE), Total surface bearing suction socket with a sleeve suspension (DEVICE), Vacuum-assisted socket system (Harmony System, Otto Bock) (DEVICE).
Who is sponsoring clinical trial NCT00985842?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00985842's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 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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