69 Participants Needed

Gait Analysis Evaluation and Orthotic for Diabetic Foot Ulcer

(NECRO Trial)

PF
Overseen ByPriscilla Frost-Larity
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

RS

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

I am over 18 years old.
I had a diabetic foot ulcer that has healed.

Exclusion Criteria

I do not have diabetes.
I have wounds that have not healed.
I cannot walk by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gait analysis and orthotic gait correction to reduce diabetic foot ulceration

12 months
Every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic
Trial Overview The study tests if using Noraxon myoRESEARCH Software for gait analysis and orthotic adjustments can lower the risk of new foot ulcers or the need for amputations in people with past foot ulcers due to diabetes.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Noraxon myoRESEARCH™ SoftwareExperimental Treatment1 Intervention
All participants will be assigned to this group to receive study intervention.

Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as myoRESEARCH Software for:
  • Biomechanical analysis
  • Gait assessment
  • Orthotic gait correction
🇺🇸
Approved in United States as myoRESEARCH Software for:
  • Gait analysis
  • Orthotic gait correction
  • Biomechanical assessment
🇨🇦
Approved in Canada as myoRESEARCH Software for:
  • Biomechanical analysis
  • Gait assessment
  • Orthotic gait correction

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Findings from Research

Custom-made cushioned footwear can reduce the risk of ulcer relapses in diabetic patients by approximately 50%, based on observations from 217 patients across various centers.
There is a need for more precise and standardized long-term studies to evaluate the effectiveness of such footwear, including better monitoring of foot pressure during walking to ensure quality control.
[Quality control and quality assurance in therapeutic shoes for the diabetic foot].Chantelau, E., Jung, V.[2006]
In a study of 61 participants with diabetes at risk for foot ulcers, the average daily wearing time of prescribed orthopaedic footwear was only 8.3 hours, with 66% of participants not adhering to the recommended wearing time of at least 60%.
Participants who consistently wore their orthopaedic footwear had significantly higher daily wearing times (12.7 hours) compared to those with inconsistent patterns (3.6 hours), highlighting the importance of stable wearing habits for effective prevention of foot ulcers.
Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study.Exterkate, SH., Jongebloed-Westra, M., Ten Klooster, PM., et al.[2023]
Wearable sensors effectively monitored gait and balance changes in elderly diabetic patients, revealing that those wearing therapeutic footwear showed significant improvements in stride length and velocity compared to those in regular footwear.
The study suggests that changes in gait parameters, influenced by the type of footwear, may be linked to the development of foot ulcers in elderly patients, highlighting the potential of wearable devices in managing this complication.
The Feasibility and Effectiveness of Wearable Sensor Technology in the Management of Elderly Diabetics with Foot Ulcer Remission: A Proof-Of-Concept Pilot Study with Six Cases.Du, C., Wang, H., Chen, H., et al.[2022]

References

[Quality control and quality assurance in therapeutic shoes for the diabetic foot]. [2006]
Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study. [2023]
The Feasibility and Effectiveness of Wearable Sensor Technology in the Management of Elderly Diabetics with Foot Ulcer Remission: A Proof-Of-Concept Pilot Study with Six Cases. [2022]
Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. [2023]
Custom-made footwear designed for indoor use increases short-term and long-term adherence in people with diabetes at high ulcer risk. [2022]
[Reliability of the novel gait analysis system RehaWatch]. [2010]
A Novel Tool for Gait Analysis: Validation Study of the Smart Insole PODOSmart®. [2021]
Inverse Kinematic Assessment of Rehabilitative Therapy in Children Using Orthotics. [2020]
Can a Biomechanical Foot Orthosis Affect Gait in Patients With Hallux Valgus? A Pilot Study. [2023]
Test-Retest Reliability of PODOSmart® Gait Analysis Insoles. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
A digital assessment and documentation tool evaluated for daily podiatric wound practice. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of moulded insoles in reducing plantar pressure in diabetic patients. [2020]
[Dynamic pedobarography in the prevention and management of diabetic foot ulcers (preliminary report)]. [2009]
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