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

Bijan Najafi, PhD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Foot Pain

Treatments: Device: Orthofeet Shoes

Study type: Interventional

Funder types: Other

Identifiers

NCT05434078

51229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group AB

Active Comparator group

Description:

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

Treatment:

Device: Orthofeet Shoes

Group BA

No Intervention group

Description:

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