A Randomized Clinical Trial Study on the Prevention Strategy and Early Detection of Ulcer Recurrence in Patients with...

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.