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NCT03927404 · ClinicalTrials.gov registry record · NA
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03927404: Completed NA study, sponsored by Indiana University.
NCT03927404 is a NA study that has completed, run by Indiana University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03927404, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket. The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented. This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.
Primary Outcome
Trans-epidermal Water Loss in 16 wks. Higher TEWL value represents a worse outcome with loss of skin barrier function. The value reported is the ratio of the TEWL of residual limb over TEWL value of the sound side limb.
Interventions
- DEVICE Active vacuum test prosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2021-09-06 |
| Phase | NA |
What the finished NCT03927404 record still lists
NCT03927404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Active vacuum test prosthesis is the first listed.
NCT03927404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03927404 about?
NCT03927404 is a clinical study titled "Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health". The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket. The prosthetic suspension plays a pivotal role in an amputee's comfort...
What is the current status of trial NCT03927404?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2020-02-12. Estimated completion is 2021-09-06.
What interventions are being tested in trial NCT03927404?
The interventions under investigation include: Active vacuum test prosthesis (DEVICE).
Who is sponsoring clinical trial NCT03927404?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03927404's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 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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