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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
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.
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGNumber of re-ulceration occurrences
Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.
Time frame: One year
Number of major proximal amputation occurrences
Number of major proximal amputation occurrences will be counted.
Time frame: One year
Change of peak plantar pressure (n/cm^2)
Assessment will be done at follow up visits.
Time frame: Every 3 months, up to one year
Change of length of gait (m)
Assessment will be done at follow up visits.
Time frame: Every 3 months, up to one year
Location of amputation
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).
Time frame: One year
Number of patients who remain in remission
Remission is defined as being ulcer free.
Time frame: One year
Percentage of patients who do not experience re-ulceration after custom orthosis
The percentage of patients who do not experience re-ulceration after custom orthosis.
Time frame: One year
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