Gait Analysis Evaluation and Orthotic for Diabetic Foot Ulcer

(NECRO Trial)

Overseen By Priscilla Frost-Larity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Non-diabetic, Non-ambulatory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

69 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{3 4 11 12 13}

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

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

Group I: Noraxon myoRESEARCH™ Software Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The SmartBoot, a smart offloading device for diabetic foot ulcers, demonstrated high accuracy in monitoring patient adherence with an average accuracy of 89.3%, which is crucial for effective healing.

Participants showed improved balance while using the SmartBoot, suggesting that it provides beneficial somatosensory feedback, and most users found it comfortable and easy to use, indicating its potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. Park, C., Mishra, R., Vigano, D., et al.[2023]

In a study of 31 participants with diabetes at high risk for foot ulcers, providing custom-made indoor footwear significantly improved adherence to wearing appropriate footwear, especially among those with initially low adherence, increasing from 65% at baseline to 87% at 12 months.

Despite the increase in footwear adherence, the one-year ulcer recurrence rate was 26%, indicating that while adherence improved, further research is needed to understand its impact on preventing foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-made footwear designed for indoor use increases short-term and long-term adherence in people with diabetes at high ulcer risk. Keukenkamp, R., van Netten, JJ., Busch-Westbroek, TE., et al.[2022]

The RehaWatch portable gait analysis system demonstrated high intraobserver reliability in measuring gait parameters among 44 healthy subjects, with Intraclass Correlation Coefficients (ICCs) ranging from 0.691 to 0.959, indicating consistent results across multiple sessions.

The study found no significant differences in gait parameters over three measurement sessions, suggesting that RehaWatch can reliably track rehabilitation progress without the complexity and expense of traditional systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reliability of the novel gait analysis system RehaWatch]. Schwesig, R., Kauert, R., Wust, S., et al.[2010]

The PODOSmart® smart insole is a portable and cost-effective tool for gait analysis, capable of measuring various gait parameters in real-life conditions, making it accessible for both healthy and pathological populations.

Validation against the Vicon stereophotogrammetry system showed that PODOSmart® provides reliable gait analysis results, with intraclass correlation coefficients (ICC) ranging from 0.313 to 0.990, indicating strong agreement for key parameters like cadence and walking speed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Tool for Gait Analysis: Validation Study of the Smart Insole PODOSmart®. Ziagkas, E., Loukovitis, A., Zekakos, DX., et al.[2021]

The study evaluated the use of OpenSim for assessing gait characteristics in 14 children using orthotic devices, showing significant improvements in muscle function and gait after four weeks of physical therapy.

All muscle lengths in the children showed less deviation from normal values post-treatment, indicating that OpenSim could be a valuable tool for quantitatively assessing rehabilitation progress in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inverse Kinematic Assessment of Rehabilitative Therapy in Children Using Orthotics. Murphy, MP., Rammer, JR., Vinehout, KL., et al.[2020]

Customized biomechanical foot orthoses (BFO) significantly improved kinematic parameters such as plantar flexion motion and hindfoot inversion in patients with hallux valgus (HV) deformities, indicating a positive effect on their gait mechanics.

While the BFO did not lead to statistically significant improvements in gait cadence, walking speed, and stride length, the observed trends suggest that BFOs may enhance overall mobility in individuals with HV deformities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a Biomechanical Foot Orthosis Affect Gait in Patients With Hallux Valgus? A Pilot Study. Lee, JY., Ryoo, HW., Ahn, SY., et al.[2023]

The PODOSmart® insoles demonstrate excellent repeatability in measuring gait analysis parameters, with test-retest reliability scores ranging from 0.802 to 0.997 based on a study of 22 healthy male adults.

This study confirms the validity of PODOSmart® insoles as a reliable tool for gait analysis, making them suitable for both research and clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-Retest Reliability of PODOSmart® Gait Analysis Insoles. Loukovitis, A., Ziagkas, E., Zekakos, DX., et al.[2021]

The Wound Healing Analyzing Tool (WHAT) demonstrated a high accuracy rate of 87% in assessing diabetic foot ulcers, aligning closely with evaluations made by a trained physician in a study involving 18 patients.

WHAT can be effectively used in clinical settings to measure wound area and condition, making it a valuable option for digital consultations, especially in areas lacking wound specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital assessment and documentation tool evaluated for daily podiatric wound practice. Jelinek, HF., Prinz, M., Wild, T.[2015]

A novel method for designing therapeutic insoles using advanced technologies like CAD/CAM and 3D digitization was developed to prevent foot sole ulcers in diabetic patients.

The study evaluated the effectiveness of four different types of insoles in reducing plantar pressure, highlighting the potential benefits of the computer-assisted design method over traditional manufacturing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of moulded insoles in reducing plantar pressure in diabetic patients. Zequera, M., Stephan, S., Paul, J.[2020]

The computer dynamic pedobarographic analysis method effectively identifies high-pressure areas on the feet of diabetic patients, which is crucial for preventing foot complications.

By using this method, orthotic specialists can create targeted interventions to relieve pressure in these areas, potentially improving patient outcomes and foot health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dynamic pedobarography in the prevention and management of diabetic foot ulcers (preliminary report)]. Tóth, K., Fabula, J.[2009]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Quality control and quality assurance in therapeutic shoes for the diabetic foot]. [2006]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Custom-made footwear designed for indoor use increases short-term and long-term adherence in people with diabetes at high ulcer risk. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Reliability of the novel gait analysis system RehaWatch]. [2010]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel Tool for Gait Analysis: Validation Study of the Smart Insole PODOSmart®. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Inverse Kinematic Assessment of Rehabilitative Therapy in Children Using Orthotics. [2020]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Can a Biomechanical Foot Orthosis Affect Gait in Patients With Hallux Valgus? A Pilot Study. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Test-Retest Reliability of PODOSmart® Gait Analysis Insoles. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A digital assessment and documentation tool evaluated for daily podiatric wound practice. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of moulded insoles in reducing plantar pressure in diabetic patients. [2020]

13. Hungary pubmed.ncbi.nlm.nih.gov

[Dynamic pedobarography in the prevention and management of diabetic foot ulcers (preliminary report)]. [2009]