NCT05434078

Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bijan Najafi, PhD · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

A clinical study at Baylor College of Medicine is being conducted to evaluate the short- and intermediate-term benefits and effectiveness of a novel pain relief footwear, Orthofeet. This 12-week randomized crossover trial aims to recruit 50 eligible ambulatory adults (aged 50 years or older) with moderate self-reported foot pain. Participants will be randomly assigned to Group AB (25 subjects) or Group BA (25 subjects), with no differences in assessments or eligibility criteria between the groups. In Group AB, participants will wear Orthofeet shoes for 6 weeks, followed by their own shoes for another 6 weeks, while Group BA will follow the reverse order. Pain and function, the primary outcomes, will be measured using the Foot Function Index (FFI), and acceptability will be assessed using a Technology Acceptance Model (TAM) questionnaire. Data will be collected at baseline, 6 weeks, and 12 weeks.

Conditions

• Foot Pain

Interventions

Type	Name	Description
DEVICE	Orthofeet Shoes	Participants will wear a pair of Orthofeet shoes to wear for 6 weeks

Timeline

• Start date: 2022-07-18
• Primary completion: 2023-08-30
• Completion: 2024-08-30
• First posted: 2022-06-27
• Last updated: 2024-12-24
• Results posted: 2024-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study