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

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this study is to identify emerging abnormal structural pathology of the vulnerable re-ulcerative diabetic foot incorporating physical therapy evaluation as well as the Noraxon gait analysis to generate quantitative and qualitative gait data. Once peak foot pressures and gait pathology is identified, gait remedy is fabricated including either a foot orthotic and/or an ankle foot prosthesis. Evaluation of constructed remedy will then be evaluated focusing on gait analysis data to validate decreased plantar foot peak pressures and gait realignment towards the reduction of the diabetic foot re-ulceration and subsequent foot or limb loss.

Official Title
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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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, Single Center, Non-Randomized, Single treatment group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noraxon myoRESEARCH™ Software<br>All participants will be assigned to this group to receive study intervention. | Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic<br>* Physical therapy evaluation (range of motion, strength, mobility, scale). Noraxon based gait assessment on treadmill while barefoot and with instrumented inner soles. Over ground walking assessment (with wireless instrumented inner soles, observational gait analysis while climbing stairs, ramps, curbs). Noraxon gait assessment and walking on treadmill will be video recorded for assessment. Standard measure of functionality and 6 minute walk test will be conducted. Patient will be fitted with corrective orthotics, based on usual care. Physical therapy re-evaluation. Noraxon based gait assessment and foot assessment (any areas of irritation, callus formation, swelling, ulcer formation, and gait mobility irregularities will be monitored and reassessed) throughout the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of re-ulceration occurrences | Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of major proximal amputation occurrences | Number of major proximal amputation occurrences will be counted. | One year | 
| Change of peak plantar pressure (n/cm^2) | Assessment will be done at follow up visits. | Every 3 months, up to one year | 
| Change of length of gait (m) | Assessment will be done at follow up visits. | Every 3 months, up to one year | 
| Location of amputation | If any amputation occurs, the location (level of amputation) will be assessed by looking at the stump or from information in patient medical records. Locations include below the knee (transtibial), at the knee (knee disarticulation), above the knee (transfemoral) and at the hip (hip disarticulation). | One year | 
| Number of patients who remain in remission | Remission is defined as being ulcer free. | One year | 
| Percentage of patients who do not experience re-ulceration after custom orthosis | The percentage of patients who do not experience re-ulceration after custom orthosis. | One year |