Activity Reduction vs Advice for Plantar Hotspots in Diabetes (MONITOR)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot; Diabetic Peripheral Neuropathy
• Intervention / Treatment: Behavioral: Individualized Objectively Monitored Activity Reduction; Behavioral: Standard Activity-Reduction Advice

Detailed Description

This is a prospective, multicenter, randomized, parallel-group, controlled proof-of-concept trial in adults with diabetes at high risk of diabetic foot ulceration.

Potential participants will undergo standardized bilateral plantar temperature assessment. A confirmed plantar thermal hotspot is defined as an inter-foot temperature difference greater than 2.2°C at the same anatomically comparable plantar site on two consecutive daily measurements. Only participants with a confirmed hotspot, intact skin at the index site, and no foot condition requiring immediate therapeutic treatment or offloading will enter the randomized trial.

Eligible participants will be randomized 1:1 to individualized, objectively monitored activity reduction or standard non-quantified activity-reduction advice. Both groups will receive guideline-concordant diabetic-foot preventive care, daily visual foot inspection, continued use of prescribed protective footwear, daily plantar-temperature monitoring, and objective step-count recording.

Participants assigned to the individualized activity-reduction group will ordinarily receive a temporary daily step-count target of no more than 50% of their objectively recorded habitual daily activity. When a 50% reduction is judged clinically inappropriate, a prespecified modified target requiring at least a 25% reduction may be used. Participants will receive feedback on their recorded activity relative to the prescribed target.

Participants assigned to the comparator group will receive standardized verbal and written advice to substantially reduce unnecessary walking and weight-bearing activity while the hotspot remains present, but they will not receive an individualized numerical step target or structured feedback comparing their activity with a prescribed target.

The primary outcome is time to uncomplicated sustained resolution of the index plantar thermal hotspot through Day 14. Sustained resolution is defined as an inter-foot temperature difference of 2.2°C or less at the index site on two consecutive valid daily measurements. Development before resolution of a clinically important foot complication requiring treatment will be considered failure to achieve uncomplicated resolution during the primary outcome period.

Participants will continue follow-up through Day 28 for assessment of hotspot recurrence, temperature-monitoring adherence, foot-related clinical outcomes, safety, and acceptability.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Hussain, M; Phone Number: 0505440153; Email: nadia.hussain@aau.ac.ae

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • Shifa International hospital
      • Contact: Saima Abbass, MD, PhD; Phone Number: 329 8123184; Email: saimaabasstahammal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized Objectively Monitored Activity Reduction; 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.	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.
Active Comparator: Standard Activity-Reduction Advice; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomization through Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomization through Day 7
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.	Historical baseline through Day 4
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.	Randomization through Day 14
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.	From sustained hotspot resolution through Day 28

Collaborators and Investigators

• Sponsor: Shifa International Hospital
• Investigators: Principal Investigator: Nadia Hussain, MD, PhD, Al Ain University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 28, 2027

Study Registration Dates

• First Submitted: September 18, 2026
• First Submitted That Met QC Criteria: September 18, 2026
• First Posted (Actual): September 25, 2026

Study Record Updates

• Last Update Posted (Actual): September 25, 2026
• Last Update Submitted That Met QC Criteria: September 18, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Diabetic foot; Peripheral neuropathy; Offloading; Thermal hotspot; Plantar foot temperature
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Diabetic Foot
• Other Study ID Numbers: SH-34988298; SIAC-02329 (Other Grant/Funding Number: Shifa Hospital Research Council grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the primary publication will be made available, together with a data dictionary, subject to applicable ethics approval, participant consent, institutional policy, and data-protection requirements.

IPD Sharing Time Frame

Beginning 12 months after publication of the primary study results and available for 5 years.

IPD Sharing Access Criteria

Data will be made available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study investigators and, where required, the sponsoring institution. Approved data will be provided for the purposes described in the approved proposal and subject to an appropriate data-use agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No