Diabetic Foot Ulcer
Conditions
Brief 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.
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
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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Single Center, Non-Randomized, Single treatment group
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of re-ulceration occurrences | One year | Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of major proximal amputation occurrences | One year | Number of major proximal amputation occurrences will be counted. |
| Change of peak plantar pressure (n/cm^2) | Every 3 months, up to one year | Assessment will be done at follow up visits. |
| Percentage of patients who do not experience re-ulceration after custom orthosis | One year | The percentage of patients who do not experience re-ulceration after custom orthosis. |
| Location of amputation | 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). |
| Number of patients who remain in remission | One year | Remission is defined as being ulcer free. |
| Change of length of gait (m) | Every 3 months, up to one year | Assessment will be done at follow up visits. |
Countries
United States
Contacts
Primary ContactPriscilla Frost-Larity
Outcome results
None listed