Effect of thermal assessment in prevention of diabetic foot ulcer: A randomized controlled study

Diabetic foot is a serious problem that prolongs hospital stay, decreases quality of life, leads to complications such as rehospitalization and amputation, and causes loss of life. In the study, it was aimed to determine the effect of thermal assessment on preventing diabetic foot ulcer in patients with Type 2 Diyabetes Mellitus (DM). The study designed as a two-arm (1:1) parallel (thermal assessment, control) prospective randomized controlled trial was conducted in the Endocrinology and General Internal Diseases Clinics of Necmettin Erbakan University Meram Medical Faculty. 70 patients older than 18 years and diagnosed with Type 2 DM who were receiving treatment and care in these clinics between January 2020-January 2023 were included in the study. 35 patients were assigned to each arm through randomization. The data collecting researcher, patients, patients' relatives, and clinic workers were blinded to group assignment. Prior to the study, ethics committee approval and institutional permission were obtained. Structured daily foot care interventions were applied by the researcher to all patients in the control arm. Foot care videos were uploaded to the mobile phones of the patients and their relatives. Differently from the control arm, thermal assessment was applied by the researcher to the patients in the thermal assessment arm with a digital infrared thermometer on the first day of the hospitalization. Thermal evaluation training video was uploaded to the mobile phones of the patients and their relatives. All patients were checked in their homes by the researcher every two months for one year. In the analysis of the data, descriptive statistics, Chi-square test, Independent Samples t test, Mann-Whitney U test, variance analysis in repetitive measurements, and mixed-design ANOVA analysis were employed. No diabetic foot ulcer development was observed in any of the two arms. Compared to the control arm, status of doing regular exercises was significantly higher in the thermal assessment arm (p=0.04). Metabolic values were similar in both arms in all follow-ups. Urine albumin value was significantly higher in the thermal evaluation arm in all three follow-ups (p<0.05). In the protective sensory evaluation made with monofilament, sensory loss was found to be significantly higher in the thermal assessment arm on heel plantar point and the 5th metatarsal pressure point (p<0.05). In all evaluations, dryness in the feet was found to be significantly higher in the control arm (p>0.05). Although it was statistically insignificant, foot care frequency of the patients in the thermal evaluation arm was higher in the second and sixth follow-ups compared to the first follow-up. It was observed that as the patients' number of steps increased, temperature also increased (p<0.05). Rash development was observed in nine patients in the thermal evaluation arm. An average increase of 0.5°C was determined in the temperature values of these patients compared to the previous week. The researcher got the patients to apply structured daily foot care regularly and to reduce the number of steps. Rash gradually disappeared in all patients without any diabetic foot ulcer development. In conclusion, as no diabetic foot ulcer developed in any of the patients, the effectiveness of thermal assessment could not be demonstrated However, temperature change that developed in the patients in the thermal assessment arm in whom rash development was observed was noticed in early period. With the necessary precautions, rash disappeared and ulcer did not develop. In line with these results, it is recommended to use more advanced computer or smart phone based devices for thermal assessment and to include structured daily foot care, thermal assessment, and number of steps in routine care protocol. Keywords: Diabet, Diabetic foot ulcer, Foot care, Thermal assessment.