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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 69 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | December 9, 2019 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT04164641 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
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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
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether taking L-Carnitine helps wound healing in adults with diabetic foot ulcers, alongside standard diabetes and wound care.
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THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers
This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.
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Pulsating electromagnetic field therapy for diabetic foot ulcers
This trial tests whether a PEMF device called CRAD ULCER X-01 helps heal chronic diabetic foot ulcers when added to standard wound care.
-
Transverse tibial bone transport to help heal chronic diabetic foot ulcers
This study tests a surgical approach called transverse tibial bone transport to see if it can help heal long‑lasting diabetic foot ulcers and prevent limb loss in adults with limited treatment options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.