Activity Reduction vs Advice for Plantar Hotspots in Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShifa International Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized Objectively Monitored Activity Reduction
BehavioralAn 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.
Standard Activity-Reduction Advice
BehavioralStandardized 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Individualized Objectively Monitored Activity ReductionExperimental treatment 1 intervention
Group B: Standard Activity-Reduction AdviceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Uncomplicated Sustained Resolution of the Index Plantar Thermal Hotspot
Number of days from randomization until the first of two consecutive valid daily measurements showing an inter-foot temperature difference ≤2.2°C at the index plantar site. Development before resolution of diabetic foot ulceration, a pre-ulcerative lesion requiring therapeutic offloading, infection, suspected Charcot neuro-osteoarthropathy, or another foot complication requiring treatment that supersedes the randomized strategy will be considered failure to achieve uncomplicated resolution during the primary outcome period.
Time frame
Randomization through Day 14Secondary outcomes
1
Proportion of Participants With Sustained Hotspot Resolution by Day 7
Proportion of randomized participants achieving uncomplicated sustained resolution of the index plantar thermal hotspot by Day 7. Sustained resolution requires an inter-foot temperature difference ≤2.2°C at the index site on two consecutive valid daily measurements without a preceding disqualifying foot complication.
Time frame
Randomization through Day 72
Percentage Change in Daily Step Count From Habitual Activity
Percentage change in mean daily step count during Days 1 through 4 after randomization relative to the participant's habitual activity level. Habitual activity is defined as the median daily step count from at least five valid days during Days -21 through -3 relative to the first positive thermal screening measurement.
Time frame
Historical baseline through Day 43
Cumulative Index-Site Temperature-Asymmetry Burden
Area under the curve of the daily absolute inter-foot temperature difference at the index plantar hotspot during the 14-day primary outcome period. Daily temperature differences are calculated from corresponding bilateral plantar temperature measurements.
Time frame
Randomization through Day 144
Proportion of Participants With Index-Hotspot Recurrence
Proportion of participants who develop a newly confirmed plantar thermal hotspot at the index site after achieving sustained resolution. Recurrence is defined using the prespecified hotspot criterion of an inter-foot temperature difference \>2.2°C at the index site on two consecutive daily measurements.
Time frame
From sustained hotspot resolution through Day 28Sponsors and contacts
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Source ClinicalTrials.gov
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