The effectiveness of a thermography-driven preventive foot care protocol on the recurrence of diabetic foot ulcers in low-medical resource settings: An open-labeled randomized controlled trial

Background: Plantar temperature monitoring, along with a comprehensive preventive foot care approach, is utilized to prevent recurrence of diabetic foot ulcers. However, there is a lack of standardized protocols for individuals with diabetic foot ulcer history in low-medical resource countries. Objective: This study investigated the efficacy of nurse-led, thermographic-evaluation-guided foot care in preventing diabetic foot ulcer recurrence in a low-medical resource country. Design: Single-blind, 1:1 allocation randomized controlled trial. Settings: Two wound care facilities with wound care nurse specialists in Indonesia. Participants: 120 patients with a diabetic foot ulcer history. Intervention: In the intervention group, baseline risk assessment including smartphone thermography evaluation was performed. Personalized foot care and education were conducted monthly for participants whose thermographs showed increased foot lesion temperature at baseline risk assessment. The control group received usual care and education using a booklet at baseline. The follow-up period was six months. Main outcome: Time to recurrence was evaluated using Kaplan–Meier survival analysis, and between-group comparisons were performed using the log-rank test. Potential risk factors were incorporated into the multivariate Cox regression model. Secondary outcomes included quality of life (European Quality of Life 5 Dimensions 3 Level Version) and foot care behavior, were analyzed using Mixed Models for Repeated Measures at baseline, third, and sixth follow-up (3 and 6 months from baseline). Results: 120 participants (intervention 60, control 60) were randomized. The intervention group had a significantly lower recurrence rate than the control group (15% vs. 35%, p = 0.011) and a significant difference in time to ulceration (log-rank test, p = 0.009) after a 6-month follow-up period. Intervention care reduced the risk of diabetic foot ulcer recurrence by 59% (Hazard ratio 0.41, 95% confidence interval 0.18, 0.96, p = 0.039) in multivariate Cox regression analysis. On the third follow-up, total diabetic foot care behavior score (p < 0.001) was significantly improved by the intervention. On the sixth follow-up, mobility (p = 0.020), self-care (p = 0.023), pain/discomfort (p < 0.001), anxiety/depression (p = 0.016), EuroQol Visual Analogue Scale score (p = 0.002), and total diabetic foot care behavior score (p < 0.001) showed significant improvements in the intervention group. Conclusions: Foot care and personalized education delivered at a frequency based on the risk level assessed by thermography effectively reduced diabetic foot ulcer recurrence, and improved quality of life and foot care behaviors. Registration number: UMIN000039012. Tweetable abstract: Nurse-led diabetic foot care and education reduced diabetic foot ulcer recurrence in Indonesia.