Can a custom Step-Count plan cool down diabetic feet?

NCT ID NCT07840300

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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing whether a personalized, monitored plan to temporarily reduce walking helps heal hot spots on the feet of adults with diabetes and nerve damage. A hot spot is a temperature difference of more than 2.2°C between matching spots on the two feet on two days in a row, which can signal a coming ulcer. Participants receive either a specific daily step target or standard advice to reduce activity, along with usual foot care and daily temperature checks. The trial measures how quickly the hot spot resolves and tracks recurrence, safety, and acceptability over 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an individualized, objectively monitored temporary walking-activity reduction plan
What this could lead to
If it works, this could give doctors a clear, measurable way to prescribe rest for feet at risk, possibly preventing painful ulcers and amputations.
What could go wrong
This is a small, early-stage trial. The step-count plan may not heal hot spots faster than standard advice, and cutting activity could have its own downsides like muscle loss or blood sugar changes.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years. * Type 1 or type 2 diabetes mellitus. * Loss of protective sensation demonstrated by standardized 10-g monofilament testing. * IWGDF risk category 3. * Previous diabetic foot ulceration and/or lower-extremity amputation consistent with IWGDF risk category 3. * Any previous ulcer on the relevant foot completely epithelialized and clinically healed for at least 4 weeks. * Confirmed plantar thermal hotspot, defined as an inter-foot temperature difference \>2.2°C at the same anatomically comparable plantar site on two consecutive days. * Intact skin at the index hotspot. * Community ambulatory. * Able to perform daily foot-temperature measurements independently or with caregiver assistance. * Able to reduce ambulatory activity temporarily if assigned to the experimental intervention. * At least five valid days of objectively recorded daily step-count data during Days -21 through -3 relative to the first positive thermal screening measurement. * Objective historical activity data available from a smartphone, smartwatch, activity tracker, pedometer with stored daily counts, or another verifiable device-based source. * Willing to continue objective activity measurement during randomized follow-up whenever technically possible. * Able to provide informed consent and complete study procedures. Exclusion Criteria: * Active diabetic foot ulcer or other open foot wound. * Blister, hemorrhagic callus, skin breakdown, or another pre-ulcerative lesion requiring immediate therapeutic management. * Active or suspected Charcot neuro-osteoarthropathy. * Clinical evidence of foot infection. * Critical limb-threatening ischaemia or another vascular condition requiring urgent management. * Recent acute foot trauma or surgery that could independently alter local foot temperature. * Predominantly non-ambulatory or wheelchair-dependent status. * Medical condition for which substantial temporary reduction in ambulatory activity would be unsafe. * Inability to provide the required pre-hotspot objective activity history. * Cognitive or functional impairment preventing study procedures without suitable caregiver assistance. * Absence of an anatomically valid contralateral comparison site for the proposed index hotspot.

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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

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  1. The places running it

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Contacts and locations

Locations

  • Shifa International hospital

    Lahore, Punjab Province, Pakistan

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