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NCT05301478 · ClinicalTrials.gov registry record · NA
Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure
A NA study of Diabetes, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05301478: Active NA study of Diabetes, sponsored by VA Office of Research and Development.
NCT05301478 is a NA study of Diabetes that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 25 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05301478, a NA study of Diabetes, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
In this research study, the investigators are evaluating if novel custom foot orthotics improves foot health and mobility for people who are at increased risk of developing foot ulcers. The investigators are comparing different methods of custom foot orthotic fabrication in people who are at increased risk of developing foot ulcers and individuals who are not. Participating in this study involves coming to the VA Hospital in Seattle for up to 12 study visits, lasting up to four hours. If eligible and choose to participate, participants will: * Wear custom foot orthotics during in laboratory testing for up to four hours * Receive a foot health assessment * Walk through the laboratory space so the investigators can see how the orthotics affect the participant's body movement * Participants will be paid for participating in the study
Primary Outcome
pressure on the bottom of the feet between insole conditions
Conditions Studied
Interventions
- DEVICE standard of care insole
- DEVICE 3D Printed Insole - pressure based
- DEVICE 3D Printed Insole - FEA
Study Locations (1)
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2026-03-30 |
| Phase | NA |
What the registry record for NCT05301478 still lists
NCT05301478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes appearing as the primary indexed condition, and to 3 interventions - of which standard of care insole is the first listed.
NCT05301478 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT05301478 about?
NCT05301478 is a clinical study titled "Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure". In this research study, the investigators are evaluating if novel custom foot orthotics improves foot health and mobility for people who are at increased risk of developing foot ulcers. The investigators are comparing different methods of custom foot orthotic fabrication in people who are at increas...
What is the current status of trial NCT05301478?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2022-03-01. Estimated completion is 2026-03-30.
What conditions does trial NCT05301478 study?
This clinical trial studies the following conditions: Diabetes.
What interventions are being tested in trial NCT05301478?
The interventions under investigation include: standard of care insole (DEVICE), 3D Printed Insole - pressure based (DEVICE), 3D Printed Insole - FEA (DEVICE).
Who is sponsoring clinical trial NCT05301478?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05301478 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05301478's enrollment target sits among peer trials
25 294th of 338 higher than 42 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes 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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