Activity Reduction vs Advice for Plantar Hotspots in Diabetes

NCT07840300 | Not Yet Recruiting DMC

• 2 other identifiers: SH-34988298SIAC-02329
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot; Diabetic Peripheral Neuropathy

Keywords

Diabetic foot; Diabetic foot ulcer; Peripheral neuropathy; Thermal hotspot; Offloading; Plantar foot temperature

Outcome Measures

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.

  Randomization through Day 14

Secondary Outcomes (4)

• Proportion of Participants With Sustained Hotspot Resolution by Day 7

  Randomization through Day 7

• Percentage Change in Daily Step Count From Habitual Activity

  Historical baseline through Day 4

• Cumulative Index-Site Temperature-Asymmetry Burden

  Randomization through Day 14

• Proportion of Participants With Index-Hotspot Recurrence

  From sustained hotspot resolution through Day 28

Study Arms (2)

Individualized Objectively Monitored Activity Reduction

EXPERIMENTAL

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

Standard Activity-Reduction Advice

ACTIVE COMPARATOR

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

Interventions

Individualized Objectively Monitored Activity Reduction BEHAVIORAL

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.

Individualized Objectively Monitored Activity Reduction

Standard Activity-Reduction Advice BEHAVIORAL

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.

Standard Activity-Reduction Advice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shifa International Hospital: lead

Study Sites (1)

Shifa International hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Nadia Hussain, MD, PhD

  Al Ain University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Hussain, M

CONTACT

0505440153; nadia.hussain@aau.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and personnel delivering activity instructions are not masked. Clinical adjudication of foot complications and central determination of hotspot-resolution outcomes from recorded temperature data will be performed without access to randomized treatment allocation wherever feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 28, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

PA (1)