Reducing Foot Pain and Peak Plantar Pressure in Patients With Foot Pain

NCT06516900 | Recruiting FDA Device

• 1 other identifier: IRB 23-0032
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The research project aims to evaluate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain.

Conditions

Foot Pain

Outcome Measures

Primary Outcomes (3)

• Foot pain

  Foot pain will be assessed using the Foot Function Index (FFI) questionnaire. It has three subsections: pain, disability, and activity limitation. The scores for the pain and disability subsections range from 0 to 90 (0 represents best and 90 represents worst), and the score for activity limitation ranges from 0 to 50 (0 represents best and 50 represents worst).

  Baseline, 6 weeks, 12 weeks

• In-shoe Peak Plantar pressure

  In-shoe peak plantar pressure data will be recorded as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal (kPa).

  Baseline, 6 weeks, 12 weeks

• Pressure-Time Integral

  Pressure-Time integral data for different foot regions will be measured as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal-sec (kPa-s).

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (2)

• Quality of life

  Baseline, 6 weeks, 12 weeks

• Physical activity

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

Own Shoe

NO INTERVENTION

Patients wearing their own appropriate shoes

OrthoFeet shoe

EXPERIMENTAL

Patients wearing OrthoFeet shoes with standard inserts

Device: OrthoFeet HandsFree Therapeutic Shoe

Interventions

OrthoFeet HandsFree Therapeutic Shoe DEVICE

Patients with foot pain will be recruited for this study and will go for an intervention of wearing OrthoFeet therapeutic shoes for 6 weeks. Each patient will be evaluated and will participate in data collection before and after intervention.

OrthoFeet shoe

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be able to give written, informed consent
• self-reported foot pain including heel pain, arch or ball of the foot pain, and hallux limitus/rigidus joint pain
• not engaged in any physician prescribed treatment plan
• in-tact protective sensation as determined using Semmes Weinstein monofilament

You may not qualify if:

• patients with plantar ulcer
• patients with major foot deformities such as charcot foot, pes cavus
• patients with lower extremity amputation including minor amputation
• foot pain because of nail disorder of keratotic lesions
• patients with unstable conditions such as recent stroke, anticipated changes in medication regime
• acute fractures of the foot
• patients with major cognitive impairment or major depression
• patients with lower extremity decreased protective sensation
• engaged in any treatment of foot pain including icing, oral anti-inflammatories, creams, injections, physical therapy
• swelling

Sponsors & Collaborators

• University of Texas Rio Grande Valley: lead

Study Sites (1)

Hafizur Rahman

Harlingen, Texas, 78550, United States

RECRUITING

Central Study Contacts

Hafizur Rahman, PhD

CONTACT

9562962035; hafizur.rahman@utrgv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: July 24, 2024
• Study Start: June 5, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: The de-identified and anonymous dataset will only be shared after the study is completed and results are published in peer-reviewed journals and conference proceedings.

Locations

US (1)