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NCT07840300

Activity Reduction vs Advice for Plantar Hotspots in Diabetes

Sponsor: Shifa International Hospital

View on ClinicalTrials.gov

Summary

This randomized proof-of-concept trial will evaluate whether an individualized, objectively monitored temporary reduction in walking activity can accelerate resolution of plantar thermal hotspots in adults with diabetes who are at high risk of foot ulceration. A plantar thermal hotspot is defined as a temperature difference greater than 2.2°C between corresponding sites on the two feet on two consecutive days. Participants with a confirmed eligible hotspot will be randomly assigned to either an individualized numerical daily step-count target or standard non-quantified advice to reduce walking and weight-bearing activity. Both groups will receive standard diabetic-foot preventive care, daily foot-temperature monitoring, and objective activity monitoring. The primary outcome is the time from randomization to sustained resolution of the index plantar thermal hotspot during the first 14 days. Participants will be followed for 28 days to assess hotspot recurrence, foot-related outcomes, safety, and acceptability.

Official title: Objectively Monitored Individualized Activity Reduction Versus Standard Advice for Resolution of Plantar Thermal Hotspots in Adults With Diabetes: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-10-01

Completion Date

2027-04-28

Last Updated

2026-09-25

Healthy Volunteers

Conditions

Diabetic Foot Diabetic Peripheral Neuropathy

Interventions

BEHAVIORAL

Individualized Objectively Monitored Activity Reduction

An individualized temporary ambulatory-activity prescription initiated after confirmation of a plantar thermal hotspot. The default daily step-count target is no more than 50% of the participant's objectively recorded habitual daily activity. If a 50% reduction is judged clinically inappropriate, a prespecified modified target requiring at least a 25% reduction may be used. Participants receive objective activity monitoring and feedback comparing actual daily steps with the prescribed target until sustained hotspot resolution.

BEHAVIORAL

Standard Activity-Reduction Advice

Standardized written and verbal advice to substantially reduce unnecessary walking and weight-bearing activity while the plantar thermal hotspot remains present. Participants do not receive an individualized numerical step-count target, percentage activity target, structured feedback comparing actual activity with a prescribed target, or escalation of the activity prescription based solely on failure to meet a numerical target. Objective step counts are recorded for study assessment.

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.

Locations (1)

Shifa International hospital

Lahore, Punjab Province, Pakistan