A Randomized Clinical Trial Study on the Prevention Strategy and Early Detection of Ulcer Recurrence in Patients with Type 2 Diabetes Mellitus Using the Risk of Recurrence Ulcer Tool.

Abstract

This study aimed to evaluate the effectiveness of prevention strategies and detect the risk level of recurrence. A randomized controlled trial (RCT) was conducted. Sixty participants were split into two groups: an intervention group consisting of 30 individuals and a control group also with 30 participants. For the intervention group, education and guidance on foot examination, foot care, dietary habits, exercise, and stress management were provided for 1 to 1.5 h each month. However, the control group only received standard care and education through a pamphlet at baseline. The both groups, the baseline risk level of ulcer recurrence score was assessed using INDIFURUTO (Indonesian Diabetic Foot Ulcer Recurrence Assessment Tool). The follow-up period was three months. A General Linear Model (GLM) repeated measures (ANCOVA) analysis was employed to compare the quality of life and risk level between the two groups at baseline and third follow-up. Risk factors for recurrence score in the intervention group significantly decreased after 3 months. These included improvements in mobility (P = .04), anxiety/depression (P < .001), EuroQol Visual Analogue Scale score (P = .004), and INDIFURUTO score (P = .004). The combination of preventive strategies could reduce the risk of recurrence ulcer and improve the quality of life.Trial registration numberClinicalTrials.gov Identifies: NCT06434922.