Gait Analysis and Orthotics for Diabetic Foot Ulcer Prevention

This study is looking at whether using Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and custom orthotics (special shoe inserts) can help reduce the chance of new diabetic foot ulcers or amputations. You may be able to join if you are between 18 and 90 years old and have had a diabetic foot ulcer that has now healed. The study will measure how many times new ulcers appear over one year to see if the intervention is successful. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 69 participants. It aims to evaluate a physical therapy evaluation combined with Noraxon-based gait assessment.
What's involved
You would undergo a physical therapy evaluation and gait assessments using special software and instrumented insoles. Custom orthotics or ankle-foot prostheses would then be made and evaluated.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to track the number of re-ulceration occurrences.

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NCT04164641

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

Recruiting
NAAges 18–90InterventionalTreatment
Johns Hopkins University
~69 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of re-ulceration occurrences
Measured over One year
Diabetic Foot Ulcer
1 sites across 1 states
Maryland1
  • Ronald Sherman, DPM, MBA · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

History of healed diabetic foot ulceration
Over 18 years of age

Exclusion

under 18 years of age
non-diabetic
non-ambulatory
non-healed wounds.
  • Number of re-ulceration occurrencesOne year

    Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.