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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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00985842
The ClinicalTrials.gov registry entry for NCT00985842 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 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 0 conditions, and to 5 interventions - of which Pe-Lite and sleeve suspension socket is the first listed.
NCT00985842 reports 0 study locations.
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.
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