MedTrace Logo

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

NCT05434078 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-24

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

Orthofeet Shoes

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

Sponsors & Collaborators

  • Orthofeet, Inc.

    collaborator UNKNOWN

  • Bijan Najafi, PhD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2023-08-30
Completion
2024-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434078 on ClinicalTrials.gov