Activity Reduction vs Advice for Plantar Hotspots in Diabetes
Key facts
- Who runs it
- Shifa International Hospital
- Where
- Pakistan1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- 1 Oct 2026
- Expected to end
- 28 Apr 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Individualized Objectively Monitored Activity Reduction
- Standard Activity-Reduction Advice
- Record updated
- 25 September 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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
Who cannot take part
- Recent acute foot trauma or surgery that could independently alter local foot temperature
- Active diabetic foot ulcer or other open foot wound
- Clinical evidence of foot infection
- Critical limb-threatening ischaemia or another vascular condition requiring urgent management
- Medical condition for which substantial temporary reduction in ambulatory activity would be unsafe
- Cognitive or functional impairment preventing study procedures without suitable caregiver assistance
- Blister, hemorrhagic callus, skin breakdown, or another pre-ulcerative lesion requiring immediate therapeutic management
- Active or suspected Charcot neuro-osteoarthropathy
- Predominantly non-ambulatory or wheelchair-dependent status
- Inability to provide the required pre-hotspot objective activity history
- Absence of an anatomically valid contralateral comparison site for the proposed index hotspot
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Individualized Objectively Monitored Activity ReductionTreatment being tested
Participants will receive standard diabetic-foot preventive care, daily plantar-temperature monitoring, and objective step-count recording, plus an individualized temporary daily step-count target. The default target will be 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 will receive feedback comparing their recorded activity with the prescribed target and will continue the temporary activity restriction until sustained hotspot resolution.
- Standard Activity-Reduction AdviceExisting treatment, for comparison
Participants will receive the same standard diabetic-foot preventive care, daily plantar-temperature monitoring, and objective step-count recording as the experimental group. They will receive standardized written and verbal advice to substantially reduce unnecessary walking and weight-bearing activity while the hotspot remains present. They will not receive an individualized numerical step-count target, percentage activity target, structured feedback comparing actual activity with a target, or escalation of the activity prescription solely because a numerical target was not achieved.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Objectively Monitored Individualized Activity Reduction Versus Standard Advice for Resolution of Plantar Thermal Hotspots in Adults With Diabetes: A Randomized Controlled Trial
- Fit questions
- Built from NCT07840300, who can take part
- Record updated
- 25 September 2026