At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Orthofeet Shoesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
In Brief
A Phase 2 clinical trial evaluating Orthofeet Shoes for Foot Pain. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFoot Pain
CountriesUnited States
CollaboratorsOrthofeet, Inc.
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartJul 2022
Primary CompletionAug 2023
Study CompletionAug 2024
TodayJul 2026
First PostedJun 27, 2022
Enrollment StartJul 18, 2022
Primary CompletionAug 30, 2023
Study CompletionAug 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.0 years ago
Interventions
Orthofeet Shoesdevice
Participants will wear a pair of Orthofeet shoes to wear for 6 weeks