Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP)

Abstract

IntroductionThe 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 methodsIn 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.ResultsOn 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).ConclusionsAt-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 numberNTR5403.

Efeito da termometria na prevenção de úlceras de pé diabético: revisão sistemática com metanálise

“…The final result were five Randomized Clinical Trials (RCTs), with a total of 828 participants, conducted in the United States 11 , 16 - 17 , Holland 31 and Norway 32 and published in English between 2004 and 2021. The characteristics of the articles reveal groups consisting mostly of aged men, diagnosed with DM2, long-term Diabetes Mellitus and high risk stratification for ulceration 2/3 1 .…”

“…United States. n=225 (IG*: 110, CG † : 115) Male: 96% Mean age: 69 years old DM2 ‡ : 100% Mean time since DM diagnosis: 13 years Risk of ulcer: 2/3 (IWGDF § ) Duration: 18 months Outcomes: Proportion of patients in each group who developed foot ulcers IG*: Handheld infrared thermometer and recording in diary CG † : Therapeutic footwear, education on diabetes, regular foot care and recording in diary Incidence of foot ulcers: IG*: 4.7% (n=5/NR || ), CG † : 12.2% (n=14/NR || ) Bus, et al 31 2021. Holland n=304 (IG*: 151, CG † : 153) Male: 72.4% Mean age: 65 DM2 ‡ : 77% Mean time since DM diagnosis: 20 years Risk of ulcer: 2/3 (IWGDF § ) Duration: 18 months Outcomes: Proportion of patients in each group who developed foot ulcers IG*: Handheld infrared thermometer and recording in a standardized form developed by the researcher.…”

“…Five RCTs involving 828 participants with diabetes were identified 11 , 16 - 17 , 31 - 32 . In a study 16 , the number of participants randomized to the intervention group (thermometry) and control group (standard health care) was not mentioned and, therefore, it was not included in the meta-analysis.…”

Response to: Remote Diabetic Foot Temperature Monitoring for Early Detection of Diabetic Foot Ulcers: A Cost-Effectiveness Analysis [Letter]

“…While this aligns with data from studies from the 2000s, the two recent trials on this topic both show effect sizes around 25%. 3 , 4 Further, recurrence rate estimates made by Brooks et al 1 for people non-adherent to temperature monitoring were similar to standard care (i.e. 40%), while these are likely higher, as non-adherence to temperature monitoring will be associated with general non-adherence to preventative treatment.…”

“…An upcoming cost-effectiveness study using empirical data based on our RCT 4 is forthcoming. Awaiting these results, modelling studies are needed, but should make realistic assumptions based on recent evidence, and should include sensitivity analyses with ranges of (realistic) assumptions.…”