Phase 2 N=50 Randomized Supportive Care

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

Foot Pain

Bottom Line

View on ClinicalTrials.gov: NCT05434078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Foot Pain at Its Worst at Baseline and Week 6 — 6.4; 5.3; 3.6; 5.4 unit on scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Orthofeet Shoes (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Bijan Najafi, PhD
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Foot Pain at Its Worst at Baseline and Week 6	6.4; 5.3; 3.6; 5.4	—
SECONDARY Step Count	5456; 4758	—
SECONDARY Daily Energy Expenditure	532; 354	—
SECONDARY Pain Score at Baseline and Week 6	34.7; 33; 22.8; 31.4	—
SECONDARY Disability at Baseline and Week 6	38.5; 35.5; 24.9; 31.4	—
SECONDARY Physical Activity Limitation	13.3; 12.2; 9.9; 10.5	—
SECONDARY Daily Metabolic Equivalent of Task (METS)	461; 427	—

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.

Eligibility Criteria

Inclusion Criteria

50 years or older
self reported foot pain including heel, arch, or ball of foot

Exclusion Criteria

Plantar ulcer Patients with major foot deformity (e.g., Charcot foot, Pes Cavus)
Lower extremity amputation including minor amputation. Foot pain because of nail disorder or keratotic lesions (e.g. corns, calluses)
unstable conditions such as recent stroke, anticipated changes in medication regime
Acute fractures of the foot
Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.
major cognitive impairment or major depression

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05434078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.