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

NCT05434078 | Completed Phase 1 Results FDA Device

• 1 other identifier: 51229
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Pain

Keywords

foot pain; falls; frailty; footwear; mobility

Outcome Measures

Primary Outcomes (1)

• Foot Pain at Its Worst at Baseline and Week 6

  Changes in foot pain from baseline to 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The FFI consists of four overall scores, including three subscales: 1) Pain Score (the primary outcome in this study), 2) Disability Score, 3) Activity Limitation Score, and 4) Overall Score. The Pain subscale asks participants to rate their foot pain on a scale of 0 (no pain) to 10 (worst imaginable pain), based on their experiences during various activities over the past two weeks. For this outcome, we focused on the FFI pain subscore related to the worst foot pain experienced over the last two weeks. To report the final results, participants from intervention A (Orthofeet) and intervention B (own shoes) were combined from groups AB and BA.

  baseline, week 6

Secondary Outcomes (6)

• Step Count

  from baseline to 6 weeks

• Daily Energy Expenditure

  from baseline to 6 weeks

• Pain Score at Baseline and Week 6

  baseline, week 6

• Disability at Baseline and Week 6

  baseline, week 6

• Physical Activity Limitation

  baseline, week 6

Study Arms (2)

Group AB

ACTIVE COMPARATOR

Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes)

Device: Orthofeet Shoes

Group BA

NO INTERVENTION

Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration

Interventions

Orthofeet Shoes DEVICE

Participants will wear a pair of Orthofeet shoes to wear for 6 weeks

Group AB

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bijan Najafi, PhD: lead
• Orthofeet, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 38776890 BACKGROUND

• 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.

  PMID: 39954566 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

+1 (424) 467-7127

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: July 18, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2024
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-12

Locations

US (1)