• Antao Ming, Ahmad Alhajjar, Isabell Walter, Claudia Piehler, Jacqueline Hoetzsch, Martin Leuckert, Vera Clemens, Andreas Petrow, Istiyak M Siddiquee, Florian G Scurt, Berend Isermann, and Peter R Mertens.
• Institute for Laboratory Medicine, Clinical Chemistry, and Molecular Diagnosis, University Hospital Leipzig, University of Leipzig; Department of Nephrology and Hypertension, Diabetes, and Endocrinology, University Hospital, Otto-von-Guericke University, Magdeburg.
• Dtsch Arztebl Int. 2024 Jan 12; 121 (1): 9169-16.

BackgroundThe worldwide prevalence of diabetic foot ulcers (DFUs) among persons with diabetes is estimated at 6.3%, with an annual incidence of 9.1 to 26.1 million persons. The early detection of asymmetrical plantar temperature elevation, followed by reduction of weight-bearing on the affected foot, may be an effective mode of prevention.MethodsPatients with diabetes and peripheral neuropathy (DFU risk groups 2/3) were monitored for plantar abnormalities with a telemedical system consisting of sole inserts with temperature sensors and photographic documentation. An open, prospective, randomized controlled trial was performed to determine whether this system prevented DFUs. The intervention and control groups were also trained in ulcer prevention and observed in follow-up at 6-month intervals for 24 months.Results283 patients were recruited. In 85 137 observation days, DFUs arose in five patients in the control group (n = 143) and in no patient in the intervention group (n = 140). The primary outcome measure was the hazard ratio, which was calculated to be 0.015 (95% confidence interval [0; 19,717]; p = 0.25) after adjustment for age, sex, severity of neuropathy, and risk class. There were 239 alarms and 75 instructions to reduce weight-bearing on the foot. The subjects carried out the telemedical application on about 70% of the days of observation. Quality of life improved in both groups.ConclusionThe tele-health system used in this trial is practical and enables the early detection of morbidity. Likely explanations for the unexpectedly low ulceration rate in this trial (and, in turn, for the lack of statistical significance) include the availability of a training program and regular follow-up examinations to patients in both arms of the trial, along with lower mobility levels due to the COVID pandemic.

23 keywords...

hide…