Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

Gait analysis and orthotic correction to prevent diabetic foot ulcers and amputations

Official title: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration

Run by Johns Hopkins University · NCT04164641 · Data updated 2026-11-12

This study tests if using special software to analyze walking patterns and creating custom foot supports can help people with a history of diabetic foot ulcers avoid getting them again and reduce the risk of amputations.

More Diabetic Foot Ulcer trials

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment69 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedDecember 9, 2019
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedDecember 16, 2025
Trial IDNCT04164641 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old with a history of healed diabetic foot ulceration.

Probably not a fit

Patients who are under 18, non-diabetic, non-ambulatory, or have non-healed wounds may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Noraxon myoRESEARCH Software for gait analysis and orthotic correction in patients with a history of diabetic foot ulcers. It aims to identify abnormal gait patterns and peak foot pressures that contribute to ulceration. Participants will receive customized orthotic devices based on their gait analysis results, with the goal of reducing the risk of re-ulceration and subsequent amputations. The study combines quantitative and qualitative data to assess improvements in gait and foot health.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of diabetic foot ulcers and the need for amputations in at-risk patients.

How similar studies have gone: Other studies have shown promising results using gait analysis and orthotic interventions for similar patient populations, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* History of healed diabetic foot ulceration
* Over 18 years of age

Exclusion Criteria:

Patients who are:

* under 18 years of age
* non-diabetic
* non-ambulatory
* non-healed wounds.

Where it's running

  • Johns Hopkins Hospital
    Baltimore, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Ronald Sherman, DPM, MBA — Johns Hopkins University
  • Study coordinator: Priscilla Frost-Larity
  • Email: pfrostl1@jhmi.edu
  • Phone: 4109555165

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.