An interventional study of Individualized Objectively Monitored Activity Reduction and Standard Activity-Reduction Advice in Diabetic Foot and Diabetic Peripheral Neuropathy, sponsored by Shifa International Hospital. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Shifa International Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Shifa International Hospital is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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 14
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 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.
Time frame: 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.
Time frame: 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.
Time frame: From sustained hotspot resolution through Day 28
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 12 months after publication of the primary study results and available for 5 years.
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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 6 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shifa International Hospital