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

NCT04164641 | Recruiting FDA Device

• 1 other identifier: IRB00208316
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of major proximal amputation occurrences

  One year

• Change of peak plantar pressure (n/cm^2)

  Every 3 months, up to one year

• Change of length of gait (m)

  Every 3 months, up to one year

• Location of amputation

  One year

• Number of patients who remain in remission

  One year

Study Arms (1)

Noraxon myoRESEARCH™ Software

EXPERIMENTAL

All participants will be assigned to this group to receive study intervention.

Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

Interventions

Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic DEVICE

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.

Noraxon myoRESEARCH™ Software

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of healed diabetic foot ulceration
• Over 18 years of age

You may not qualify if:

• Patients who are:
• under 18 years of age
• non-diabetic
• non-ambulatory
• non-healed wounds.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Ronald Sherman, DPM, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscilla Frost-Larity

CONTACT

4109555165; pfrostl1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Single Center, Non-Randomized, Single treatment group

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: December 9, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)