Recruiting

Orthotic Gait Correction

Sponsor:

Johns Hopkins University

Code:

NCT04164641

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

Study Details

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

Study ID

NCT04164641

Start date

Dec 9, 2019

Status verified date

Dec, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

69 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Noraxon myoRESEARCH™ Software

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

Interventions

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.

Primary outcome measure

  • Number of re-ulceration occurrences [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Priscilla Frost-Larity

4109555165pfrostl1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-12-16.