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NCT05434078 · ClinicalTrials.gov registry record · Phase 1
Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear
A Phase 1 study, sponsored by Bijan Najafi, PhD.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT05434078: Completed Phase 1 study, sponsored by Bijan Najafi, PhD.
NCT05434078 is a Phase 1 study that has completed, run by Bijan Najafi, PhD. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05434078, a Phase 1 study, has completed, sponsored by Bijan Najafi, PhD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulting in increased daily physical activity, objectively measured using validated wearable devices.
Primary Outcome
Changes in foot pain from baseline to 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The FFI consists of four overall scores, including three subscales: 1) Pain Score (the primary outcome in this study), 2) Disability Score, 3) Activity Limitation Score, and 4) Overall Score. The Pain subscale asks participants to rate their foot pain on a scale of 0 (no pain) to 10 (worst imaginable pain), based on their experiences d
Interventions
- DEVICE Orthofeet Shoes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2024-08-30 |
| Phase | Phase 1 |
What the finished NCT05434078 record still lists
NCT05434078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which Orthofeet Shoes is the first listed.
NCT05434078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05434078 about?
NCT05434078 is a clinical study titled "Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear". The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulti...
What is the current status of trial NCT05434078?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-07-18. Estimated completion is 2024-08-30.
What interventions are being tested in trial NCT05434078?
The interventions under investigation include: Orthofeet Shoes (DEVICE).
Who is sponsoring clinical trial NCT05434078?
This trial is sponsored by Bijan Najafi, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05434078's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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