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
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
Sponsors
Source
Johns Hopkins University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
Yes
Is Unapproved Device
No
Is Ppsd
No
Is Us Export
Yes
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.
Overall Status
Not yet recruiting
Start Date
2019-12-06
Completion Date
2023-12-06
Primary Completion Date
2023-12-06
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Number of re-ulceration occurrences |
One year |
Secondary Outcome
Measure |
Time Frame |
|
Number of major proximal amputation occurrences |
One year |
|
Change of peak plantar pressure (n/cm^2) |
Every 3 months, up to one year |
|
Change of length of gait (m) |
Every 3 months, up to one year |
|
Location of amputation |
One year |
|
Number of patients who remain in remission |
One year |
|
Percentage of patients who do not experience re-ulceration after custom orthosis |
One year |
Enrollment
69
Condition
Intervention
Intervention Type
Device
Intervention Name
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.
Arm Group Label
Noraxon myoRESEARCH™ Software
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.
Gender
All
Minimum Age
18 Years
Maximum Age
90 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ronald Sherman, DPM, MBA |
Principal Investigator |
Johns Hopkins University |
Overall Contact
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Noraxon myoRESEARCH™ Software
Arm Group Type
Experimental
Description
All participants will be assigned to this group to receive study intervention.
Firstreceived Results Date
N/A
Acronym
NECRO
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Intervention Model Description
Prospective, Single Center, Non-Randomized, Single treatment group
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
November 13, 2019
Study First Submitted Qc
November 13, 2019
Study First Posted
November 15, 2019
Last Update Submitted
November 14, 2019
Last Update Submitted Qc
November 14, 2019
Last Update Posted
November 18, 2019
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.