Introduction The skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. This allows for early recognition of imminent ulcers. We assessed whether at-home monitoring of plantar foot skin temperature can help prevent ulcer recurrence in diabetes. Research design and methods In this parallel-group outcome-assessor-blinded multicenter randomized controlled trial (7 hospitals, 4 podiatry practices), we randomly assigned people with diabetes, neuropathy, foot ulcer history (<4 years, n=295), or Charcot’s neuro-arthropathy (n=9) to usual care (ie, podiatric treatment, education, and therapeutic footwear) or usual care plus measuring skin temperatures at 6–8 plantar sites per foot each day (enhanced therapy). If ∆T>2.2°C between corresponding sites on the left and right foot for two consecutive days, participants were instructed to reduce ambulatory activity until this hotspot disappeared and contact their podiatrist. Primary outcome was ulcer recurrence in 18 months on the plantar foot, interdigital, or medial/lateral/anterior forefoot surfaces; secondary outcome was ulcer recurrence at any foot site. Results On the basis of intention-to-treat, 44 of 151 (29.1%) participants in enhanced therapy and 57 of 153 (37.3%) in usual care had ulcer recurrence at a primary outcome site (RR: 0.782 (95%CI 0.566 to 1.080), p=0.133). Of the 83 participants in enhanced therapy who measured a hotspot, the 24 subsequently reducing their ambulatory activity had significantly fewer ulcer recurrences (n=3) than those in usual care (RR: 0.336 (95% CI 0.114 to 0.986), p=0.017). Enhanced therapy was effective over usual care for ulcer recurrence at any foot site (RR: 0.760 (95% CI 0.579 to 0.997), p=0.046). Conclusions At-home foot temperature monitoring does not significantly reduce incidence of diabetic foot ulcer recurrence at or adjacent to measurement sites over usual care, unless participants reduce ambulatory activity when hotspots are found, or when aiming to prevent ulcers at any foot site. Trial registration number NTR5403. Data are available upon reasonable request. Data supporting the results are available on request from the authors.

中文翻译：

---

家庭皮肤温度监测在降低糖尿病患者足部溃疡复发率方面的有效性：一项多中心随机对照试验 (DIATEMP)

介绍 糖尿病足患者的皮肤被认为会因走动活动而发热，然后才会分解为溃疡。这允许及早识别即将发生的溃疡。我们评估了在家监测足底皮肤温度是否有助于预防糖尿病溃疡复发。研究设计和方法 在这项平行组结果评估者盲法多中心随机对照试验（7 家医院，4 家足科诊所）中，我们随机分配患有糖尿病、神经病变、足部溃疡病史（<4 年，n=295）或Charcot 神经关节病 (n=9) 到常规护理（即足病治疗、教育和治疗鞋类）或常规护理加上每天每英尺 6-8 个足底部位测量皮肤温度（增强治疗）。如果ΔT>2。连续两天左右脚相应部位之间的温度为 2°C，参与者被指示减少走动活动，直到该热点消失并联系他们的足病医生。主要结果是足底、趾间或前足内侧/外侧/前表面的溃疡在 18 个月内复发；次要结果是足部任何部位的溃疡复发。结果 在意向治疗的基础上，151 名参与者中有 44 名 (29.1%) 接受强化治疗，153 名参与者中有 57 名 (37.3%) 在主要结果部位出现溃疡复发 (RR: 0.782 (95%CI 0.566)到 1.080），p=0.133）。在测量热点的 83 名接受增强治疗的参与者中，24 名随后减少其走动活动的参与者的溃疡复发 (n=3) 显着低于常规治疗中的参与者 (RR: 0.336 (95% CI 0.114 to 0.986), p=0.017) ）。对于足部任何部位的溃疡复发，强化治疗比常规治疗更有效（RR：0.760（95% CI 0.579 至 0.997），p=0.046）。结论 与常规护理相比，在家中足部温度监测并不能显着降低测量部位或测量部位附近糖尿病足溃疡复发的发生率，除非参与者在发现热点时减少走动活动，或旨在预防任何足部部位的溃疡。试用注册号 NTR5403。可应合理要求提供数据。支持结果的数据可应作者要求提供。结论 与常规护理相比，在家中足部温度监测并不能显着降低测量部位或测量部位附近糖尿病足溃疡复发的发生率，除非参与者在发现热点时减少走动活动，或旨在预防任何足部部位的溃疡。试用注册号 NTR5403。可应合理要求提供数据。支持结果的数据可应作者要求提供。结论 与常规护理相比，在家中足部温度监测并不能显着降低测量部位或测量部位附近糖尿病足溃疡复发的发生率，除非参与者在发现热点时减少走动活动，或旨在预防任何足部部位的溃疡。试用注册号 NTR5403。可应合理要求提供数据。支持结果的数据可应作者要求提供。