Re-Ulceration Is Common in Persons with Diabetes and Healed Foot Ulcer After Participant-Driven Education in Group: A Randomized Controlled Trial.

Objective: To compare the number of ulcer-free days during 24 months in persons with diabetes and a healed foot ulcer below the ankle provided with adjusted therapeutic shoes who were given standard information and participated in participant-driven group education compared with standard information alone. Methods: A randomized controlled trial was designed to evaluate the number of ulcer-free days after participant-driven group education in addition to standard information compared with standard information alone. The number needed to treat (N = 174) was not met, as only 138 persons with diabetes and previously healed foot ulcer were recruited (age median 63 years [34-79], 101 men/37 women). Results: A total of 138 persons were recruited, of whom 107 (77.5%) completed the study, 7 (5%) dropped out, and 12 (9%) deceased. No statistically significant difference was found between the intervention group compared with the control group after 6, 18, or 24 months. After 12 months, more patients in the intervention group had developed ulcers. Seventy-seven participants (56%) developed new foot ulcers, irrespective of side and site. Development of one ulcer appeared in 36 participants, two ulcers in 19, and 22 participants developed three ulcers. Forty-eight participants remained ulcer-free (35%) during the 24-month follow-up. Median ulcer-free days until first ulceration were 368 (4-720); until second ulceration, 404 (206-631); and until third ulceration, 660 (505-701). The participants wore prescribed therapeutic shoes during 88% of the follow-up visits. Conclusions: One-third of the participants remained ulcer-free for 24 months. Patient-driven education in groups did not give better results than standard information in this underpowered study. This study illustrates the challenges to perform comparative preventive studies in this group of patients with extensive comorbidity. Further studies are needed to evaluate interventions on ulceration in persons with a healed foot ulcer.