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Behavioural Intervention

Gait Analysis Evaluation and Orthotic for Diabetic Foot Ulcer (NECRO Trial)

N/A
Recruiting
Led By Ronald Sherman, DPM, MBA
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Over 18 years of age
Over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

NECRO Trial Summary

This trial is testing whether a special software system and orthotic devices can help reduce the risk of diabetic foot ulcers or amputation.

Who is the study for?
This trial is for adults over 18 with a history of healed diabetic foot ulcers. It's not suitable for those who can't walk, are under 18, don't have diabetes, or currently have non-healed wounds.Check my eligibility
What is being tested?
The study tests if using Noraxon myoRESEARCH Software for gait analysis and orthotic adjustments can lower the risk of new foot ulcers or the need for amputations in people with past foot ulcers due to diabetes.See study design
What are the potential side effects?
Since this trial involves gait analysis and use of custom orthotics rather than medication, side effects may include discomfort from wearing the orthotics or potential skin irritation at contact points.

NECRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
I am over 18 years old.
Select...
I had a diabetic foot ulcer that has healed.

NECRO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of re-ulceration occurrences
Secondary outcome measures
Change of length of gait (m)
Change of peak plantar pressure (n/cm^2)
Location of amputation
+3 more

NECRO Trial Design

1Treatment groups
Experimental Treatment
Group I: Noraxon myoRESEARCH™ SoftwareExperimental Treatment1 Intervention
All participants will be assigned to this group to receive study intervention.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,701 Total Patients Enrolled
3 Trials studying Foot Ulcer
292 Patients Enrolled for Foot Ulcer
Ronald Sherman, DPM, MBAPrincipal InvestigatorJohns Hopkins University

Media Library

Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04164641 — N/A
Foot Ulcer Research Study Groups: Noraxon myoRESEARCH™ Software
Foot Ulcer Clinical Trial 2023: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Highlights & Side Effects. Trial Name: NCT04164641 — N/A
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04164641 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile qualify me for enrollment in this research?

"The trial is currently open to 69 participants with diabetic foot who are 18 years old or older. The most noteworthy requirement for admission is that potential subjects must be of legal age."

Answered by AI

Are new participants still being admitted to this clinical experiment?

"As reported on clinicaltrials.gov this medical study is still actively seeking participants since it was first posted on December 9th 2019 and last updated on December 7th 2021."

Answered by AI

How many participants is the clinical trial currently recruiting?

"Indeed, the information on clinicaltrials.gov reveals that recruitment for this medical study is active. The initiative was originally posted to the website in December 2019 and has since been updated as recently as 12/7/2021. With 1 location taking part, 69 participants are needed to complete the trial."

Answered by AI

Are participants of this trial required to be over 18 years old?

"According to the trial parameters, only applicants aged 18 to 90 are eligible for this study. Those younger than 18 are able to join 51 other clinical trials and those over 65 can select from 350 additional studies."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Dec 2024