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NCT Number: NCT04164641

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of re-ulceration occurrences

    Time frame: One year

    Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.

Secondary outcomes

  1. Number of major proximal amputation occurrences

    Time frame: One year

    Number of major proximal amputation occurrences will be counted.

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

    Time frame: Every 3 months, up to one year

    Assessment will be done at follow up visits.

  3. Change of length of gait (m)

    Time frame: Every 3 months, up to one year

    Assessment will be done at follow up visits.

  4. Location of amputation

    Time frame: 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).

  5. Number of patients who remain in remission

    Time frame: One year

    Remission is defined as being ulcer free.

  6. Percentage of patients who do not experience re-ulceration after custom orthosis

    Time frame: One year

    The percentage of patients who do not experience re-ulceration after custom orthosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Priscilla Frost-Larity

CONTACT

[email protected]

4109555165

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: NECRO

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Nov 15, 2019
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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