Walking analysis may save diabetic feet from ulcers and amputation
NCT ID NCT04164641
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using special gait analysis software and custom shoe inserts (orthotics) can help people with a history of diabetic foot ulcers avoid new ulcers and amputations. Researchers will analyze how participants walk and fit them with corrective orthotics. The goal is to see if this approach reduces re-ulceration rates in 69 adults with healed diabetic foot ulcers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- custom corrective orthotics
- What this could lead to
- If successful, this approach could provide a non-invasive way to prevent recurring foot ulcers and reduce the risk of amputation in diabetic patients.
- What could go wrong
- This is a small, early-stage study with only 69 participants, so results may not apply to everyone. The intervention is a device and therapy, not a drug, so benefits may be modest and depend on consistent use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gene therapy shots aim to save legs from amputation in diabetes
- New wound dressing put to the test against diabetic foot ulcers
- Silver and sound: can ultrasound push nanoparticles into diabetic wounds?
- Zapping a leg nerve: can a wearable device help stubborn ulcers heal?
- Wound dressings that trap microbes: scientists test a Drug-Free approach
- Can a traditional herbal mix save limbs from diabetic ulcers?