Gait analysis and orthotic correction to prevent diabetic foot ulcers and amputations
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04164641 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a history of healed diabetic foot ulceration.
Not a fit: Patients who are under 18, non-diabetic, non-ambulatory, or have non-healed wounds may not benefit from this study.
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 performed: Other studies have shown promising results using gait analysis and orthotic interventions for similar patient populations, indicating potential for success.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.