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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Device 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 cor
Primary outcome measures
- Number of re-ulceration occurrences [Time frame: One year]
Secondary outcome measures (6)
- Number of major proximal amputation occurrences [Time frame: One year]
- Change of peak plantar pressure (n/cm^2) [Time frame: Every 3 months, up to one year]
- Change of length of gait (m) [Time frame: Every 3 months, up to one year]
- Location of amputation [Time frame: One year]
- Number of patients who remain in remission [Time frame: One year]
- Percentage of patients who do not experience re-ulceration after custom orthosis [Time frame: One year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT04164641 · IRB00208316