RecruitingNot ApplicableNCT04164641

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


Sponsor

Johns Hopkins University

Enrollment

69 participants

Start Date

Dec 9, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria2

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

Exclusion Criteria5

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

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Interventions

DEVICENoraxon 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(1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT04164641


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