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NCT06026813 · ClinicalTrials.gov registry record · NA
Pressure Alternating Shoes
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT06026813: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT06026813 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 21 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
NCT06026813, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The project is designed to develop and test Pressure Alternating Shoes (PAS), which will periodically off-load certain regions of the foot in order to prevent foot ulcers. An automated dual layer insole compromised of an active pressurized actuator array in combination with a passive compliant layer on top of each actuator to modulate and distribute the plantar surface pressure as desired will be tested. This device will allow us to simultaneously load and offload select areas of the foot using the active layer by inflating and deflating individual actuators using pressurized air. After offloading, the remaining load will be distributed to other areas with inflated actuators. Automatic modulation will be provided through programmable control hardware which will cyclically relieve mechanical loading based on a prescribed duration and frequency.
Primary Outcome
Maximum Average pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot.
Interventions
- DEVICE test pressure alternating shoes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2024-07-11 |
| Phase | NA |
What the finished NCT06026813 record still lists
NCT06026813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 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 1 intervention - of which test pressure alternating shoes is the first listed.
NCT06026813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06026813 about?
NCT06026813 is a clinical study titled "Pressure Alternating Shoes". The project is designed to develop and test Pressure Alternating Shoes (PAS), which will periodically off-load certain regions of the foot in order to prevent foot ulcers. An automated dual layer insole compromised of an active pressurized actuator array in combination with a passive compliant layer...
What is the current status of trial NCT06026813?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2024-03-07. Estimated completion is 2024-07-11.
What interventions are being tested in trial NCT06026813?
The interventions under investigation include: test pressure alternating shoes (DEVICE).
Who is sponsoring clinical trial NCT06026813?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06026813's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 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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