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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 (NECRO)

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Johns Hopkins University

Status

Enrolling

Conditions

Diabetic Foot Ulcer

Treatments

Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

Study type

Interventional

Funder types

Other

Identifiers

NCT04164641
IRB00208316

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

69 participants in 1 patient group

Noraxon myoRESEARCH™ Software
Experimental group
Description:
All participants will be assigned to this group to receive study intervention.
Treatment:
Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

Trial contacts and locations

1

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Central trial contact

Priscilla Frost-Larity

Data sourced from clinicaltrials.gov

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