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

Diabetic Foot Ulcer Clinical Trial

— NECRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164641
• Other study ID #: IRB00208316
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Priscilla Frost-Larity
• Phone: 4109555165
• Email: pfrostl1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: June 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of major proximal amputation occurrences	Number of major proximal amputation occurrences will be counted.	One year
Secondary	Change of peak plantar pressure (n/cm^2)	Assessment will be done at follow up visits.	Every 3 months, up to one year
Secondary	Change of length of gait (m)	Assessment will be done at follow up visits.	Every 3 months, up to one year
Secondary	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
Secondary	Number of patients who remain in remission	Remission is defined as being ulcer free.	One year
Secondary	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