Gait Analysis Evaluation and Orthotic for Diabetic Foot Ulcer
(NECRO Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic for diabetic foot ulcers?
Research suggests that custom-made cushioned footwear can prevent about 50% of ulcer relapses in diabetic patients, and using technology to monitor foot pressures during walking may improve the quality of such footwear. Additionally, wearable sensors have shown potential benefits in managing diabetic foot complications by monitoring gait and balance changes.12345
Is the Gait Analysis Evaluation and Orthotic system safe for use in humans?
The studies reviewed do not provide specific safety data for the Gait Analysis Evaluation and Orthotic system, but similar gait analysis tools like PODOSmart® and RehaWatch have been shown to be reliable and valid for measuring walking patterns in healthy individuals, suggesting they are generally safe for use.678910
How does the Noraxon myoRESEARCH Software Gait Analysis Evaluation and Orthotic treatment differ from other treatments for diabetic foot ulcers?
The Noraxon myoRESEARCH Software Gait Analysis Evaluation and Orthotic treatment is unique because it uses advanced software to analyze gait (the way a person walks) and balance, which can help in customizing orthotics (special shoe inserts) to prevent and manage diabetic foot ulcers. This approach focuses on understanding and modifying walking patterns to reduce pressure on the feet, unlike traditional treatments that may not use such detailed gait analysis.34111213
What is the purpose of this trial?
Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot ulceration.
Research Team
Ronald Sherman, DPM, MBA
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for adults over 18 with a history of healed diabetic foot ulcers. It's not suitable for those who can't walk, are under 18, don't have diabetes, or currently have non-healed wounds.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gait analysis and orthotic gait correction to reduce diabetic foot ulceration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic is already approved in European Union, United States, Canada for the following indications:
- Biomechanical analysis
- Gait assessment
- Orthotic gait correction
- Gait analysis
- Orthotic gait correction
- Biomechanical assessment
- Biomechanical analysis
- Gait assessment
- Orthotic gait correction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor