CompletedPhase 1/2

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

United States50 participantsStarted 2022-07-18

Plain-language 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.

Who can participate

Age range50 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Foot Pain at Its Worst at Baseline and Week 6

Timeframe: baseline, week 6

Trial details

NCT IDNCT05434078

SponsorBijan Najafi, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-30

Results submitted2024-11-18

View on ClinicalTrials.gov More Foot Pain trials