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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

• Registration Number: NCT04164641
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Study Start: 2019-12-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Noraxon myoRESEARCH™ Software	Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic	All participants will be assigned to this group to receive study intervention.

Primary Outcome Measures

Name	Time	Method
Number of re-ulceration occurrences	One year	Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.

Secondary Outcome Measures

Name	Time	Method
Change of length of gait (m)	Every 3 months, up to one year	Assessment will be done at follow up visits.
Number of major proximal amputation occurrences	One year	Number of major proximal amputation occurrences will be counted.
Location of amputation	One year	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).
Number of patients who remain in remission	One year	Remission is defined as being ulcer free.
Percentage of patients who do not experience re-ulceration after custom orthosis	One year	The percentage of patients who do not experience re-ulceration after custom orthosis.
Change of peak plantar pressure (n/cm^2)	Every 3 months, up to one year	Assessment will be done at follow up visits.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States