Therapeutic footwear becomes the first treatment line in the prevention of diabetic foot ulcer and future complications of diabetes. Previous studies and the International Working Group on the Diabetic Foot have described therapeutic footwear as a protective factor to reduce the risk of re-ulceration. In this study, we aimed to analyze the efficacy of a rigid rocker sole to reduce the recurrence rate of plantar ulcers in patients with diabetic foot. Between June 2016 and December 2017, we conducted a randomized controlled trial in a specialized diabetic foot unit. Fifty-one patients with diabetic neuropathy who had a recently healed plantar ulcer were randomized consecutively into the following two groups: therapeutic footwear with semi-rigid sole (control) or therapeutic footwear with a rigid rocker sole (experimental). All patients included in the study were followed up for 6 months (one visit each 30 ± 2 days) or until the development of a recurrence event. Primary outcome measure was recurrence of ulcers in the plantar aspect of the foot. A total of 51 patients were randomized to the control and experimental groups. The median follow-up time was 26 [IQR-4.4-26.1] weeks for both groups. On an intention-to-treat basis, 16 (64%) and 6 (23%) patients in the control and experimental groups had ulcer recurrence, respectively. Among the group with >60% adherence to therapeutic footwear, multivariate analysis showed that the rigid rocker sole improved ulcer recurrence-free survival time in diabetes patients with polyneuropathy and DFU history (P = 0.019; 95% confidence interval, 0.086-0.807; hazard ratio, 0.263). We recommend the use of therapeutic footwear with a rigid rocker sole in patients with diabetes with polyneuropathy and history of diabetic foot ulcer to reduce the risk of plantar ulcer recurrence. ClinicalTrials.gov NCT02995863.

Multidrug-resistant organism infections have become important in recent years due to the increased prevalence of diabetic foot ulcers and their possible consequences. This study aimed to systematically review and evaluate ulcer duration, healing time, hospital stay, amputation, and mortality rates in patients with diabetic foot ulcers caused by infection with multidrug-resistant organisms. PubMed, the Cochrane Library, and Web of Science were searched in May 2020 to find observational studies in English about the clinical outcomes of multidrug-resistant organism infection in diabetic foot ulcers. Eight studies met the inclusion criteria, and these studies included 923 patients. The overall methodological quality of the study was moderate. Ulcer duration was described in six studies, and there was no practical association with multidrug-resistant organisms. Two out of three studies reported a longer healing time in multidrug-resistant organism infections than in non-multidrug-resistant organism infections. Clinical outcomes included the duration of hospitalisation, surgeries, amputations, and deaths. Lower limb amputation was the most reported clinical outcome in the included studies, and was more prevalent in the multidrug-resistant organism infections. We concluded that there was not enough evidence that multidrug-resistant organisms hindered the healing of diabetic foot ulcers. In contrast to the clinical outcomes, multidrug-resistant organisms affect both amputation rates and mortality rates.