Objectively Monitored Individualized Activity Reduction Versus Standard Advice for Resolution of Plantar Thermal Hotspots in Adults With Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to Uncomplicated Sustained Resolution of the Index Plantar Thermal Hotspot
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Type 1 or type 2 diabetes mellitus.
- •Loss of protective sensation demonstrated by standardized 10-g monofilament testing.
- •IWGDF risk category
- •Previous diabetic foot ulceration and/or lower-extremity amputation consistent with IWGDF risk category
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Individualized Objectively Monitored Activity Reduction (Behavioral)
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.
干预措施: Standard Activity-Reduction Advice (Behavioral)
结局指标
主要结局
Time to Uncomplicated Sustained Resolution of the Index Plantar Thermal Hotspot
时间窗: Randomization through Day 14
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.
次要结局
- Proportion of Participants With Index-Hotspot Recurrence(From sustained hotspot resolution through Day 28)
- 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)
研究者
Saima Abass Tahammal
Medical Director
Shifa International Hospital