Clinical trial NCT05434078: Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear
Official title: Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Foot Pain
Keywords: foot pain
falls
frailty
footwear
mobility
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Orthofeet, Inc.
First posted: 2022-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Foot Pain at Its Worst at Baseline and Week 6
timeFrame: baseline, week 6
Secondary outcomes:
measure: Step Count
timeFrame: from baseline to 6 weeks
measure: Daily Energy Expenditure
timeFrame: from baseline to 6 weeks
measure: Pain Score at Baseline and Week 6
timeFrame: baseline, week 6
measure: Disability at Baseline and Week 6
timeFrame: baseline, week 6
measure: Physical Activity Limitation
timeFrame: baseline, week 6
measure: Daily Metabolic Equivalent of Task (METS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Finco MG, Ouattas A, El-Refaei N, Momin AS, Azarian M, Najafi B. Assessing the Acceptability and Effectiveness of a Novel Therapeutic Footwear in Reducing Foot Pain and Improving Function among Older Adults: A Crossover Randomized Controlled Trial. Gerontology. 2024;70(8):842-854. doi: 10.1159/000539307. Epub 2024 May 22.
citation: Ouattas A, Finco MG, Dehghan Rouzi M, Azarian M, Rojas AZ, Bargas Ochoa M, El-Refaei N, Momin A, Najafi B. The role of therapeutic footwear to increase daily physical activity in older adults with chronic foot pain. Clin Biomech (Bristol). 2025 Mar;123:106373. doi: 10.1016/j.clinbiomech.2024.106373. Epub 2024 Oct 29.