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)
Primary Purpose
Diabetic Foot Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
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.
Sites / Locations
- Johns Hopkins HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Noraxon myoRESEARCH™ Software
Arm Description
All participants will be assigned to this group to receive study intervention.
Outcomes
Primary Outcome Measures
Number of re-ulceration occurrences
Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.
Secondary Outcome Measures
Number of major proximal amputation occurrences
Number of major proximal amputation occurrences will be counted.
Change of peak plantar pressure (n/cm^2)
Assessment will be done at follow up visits.
Change of length of gait (m)
Assessment will be done at follow up visits.
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).
Number of patients who remain in remission
Remission is defined as being ulcer free.
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.
Full Information
NCT ID
NCT04164641
First Posted
November 13, 2019
Last Updated
December 6, 2022
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04164641
Brief Title
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
Acronym
NECRO
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
December 6, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, Single Center, Non-Randomized, Single treatment group
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Noraxon myoRESEARCH™ Software
Arm Type
Experimental
Arm Description
All participants will be assigned to this group to receive study intervention.
Intervention Type
Device
Intervention Name(s)
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of re-ulceration occurrences
Description
Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of major proximal amputation occurrences
Description
Number of major proximal amputation occurrences will be counted.
Time Frame
One year
Title
Change of peak plantar pressure (n/cm^2)
Description
Assessment will be done at follow up visits.
Time Frame
Every 3 months, up to one year
Title
Change of length of gait (m)
Description
Assessment will be done at follow up visits.
Time Frame
Every 3 months, up to one year
Title
Location of amputation
Description
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
Title
Number of patients who remain in remission
Description
Remission is defined as being ulcer free.
Time Frame
One year
Title
Percentage of patients who do not experience re-ulceration after custom orthosis
Description
The percentage of patients who do not experience re-ulceration after custom orthosis.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priscilla Frost-Larity
Phone
4109555165
Email
pfrostl1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Sherman, DPM, MBA
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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