Diabetic Foot UlcerNECRONCT04164641
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
A study testing Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic in people with Diabetic Foot Ulcer, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of healed diabetic foot ulceration
- Over 18 years of age
Who cannot join
- Patients who are:
- under 18 years of age
- non-diabetic
- non-ambulatory
- non-healed wounds.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and OrthoticDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Noraxon myoRESEARCH™ Software | Experimental | All participants will be assigned to this group to receive study intervention. Receives: Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of re-ulceration occurrences
Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.
Measured: One year
Secondary outcomes (6)
Number of major proximal amputation occurrences
Number of major proximal amputation occurrences will be counted.
Measured: One year
Change of peak plantar pressure (n/cm^2)
Assessment will be done at follow up visits.
Measured: Every 3 months, up to one year
Change of length of gait (m)
Assessment will be done at follow up visits.
Measured: 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).
Measured: One year
Number of patients who remain in remission
Remission is defined as being ulcer free.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start9 Dec 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Single Center, Non-Randomized, Single treatment group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Sherman, DPM, MBA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164641
- Sponsor's protocol ID
- IRB00208316
- Acronym
- NECRO
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04164641
- Acronym / sponsor ID
- NECRO / IRB00208316
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Single Center, Non-Randomized, Single treatment group
| Arm | Type | Receives |
|---|---|---|
| Noraxon myoRESEARCH™ Software | Experimental | Device: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and OrthoticAll participants will be assigned to this group to receive study intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of healed diabetic foot ulceration
- Over 18 years of age
Key exclusion criteria (5 listed)
- under 18 years of age
- non-diabetic
- non-ambulatory
- non-healed wounds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and OrthoticPhysical 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. | Device | Noraxon myoRESEARCH™ Software |
Primary outcome
Number of re-ulceration occurrences
Time frame: One year
Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald Sherman, DPM, MBA principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic in people with Diabetic Foot Ulcer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priscilla Frost-Larity (4109555165, pfrostl1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of re-ulceration occurrences (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.