OBJECTIVE The aim of this study was to evaluate the effects of needle flexor tendon tenotomy treatment of the diabetic hammertoe deformity. RESEARCH DESIGN AND METHODS A multicenter randomized controlled trial of individuals with diabetes and ulcers or impending ulcers associated with hammertoes was performed between 1 November 2019 and 31 March 2021. Participants were stratified by the presence of ulcers or impending ulcers. Participants were randomly assigned to tenotomy and standard nonsurgical treatment or to standard nonsurgical treatment alone. Primary outcomes were time to ulcer healing and progression from impending ulcer to active ulcer. RESULTS Of 224 screened participants with diabetes, 95 (59.0% men) were included. The mean follow-up was 291 ± 70 days, 28 (29.5%) had type 1 diabetes, mean diabetes (presented with 25–75% quartile) duration was 20 (13–26) years, and mean age was 67.7 ± 9.8 years. Of the included participants, 16 had ulcers, of whom 8 were randomly assigned to intervention. Of the remaining 79 with impending ulcers, 39 were randomly assigned to intervention. For participants with ulcers, healing rates favored tenotomy (100% vs 37.5%, P = 0.026) as did time to ulcer healing (P = 0.04). For those with impending ulcers, incidence of progression to an active ulcer was lower (1 vs 7, P = 0.028) and the number of ulcer-free days higher (P = 0.043) in the tenotomy group. No serious adverse events were recorded. CONCLUSIONS This randomized study showed that the simple procedure of needle flexor tendon tenotomy was effective and safe when treating and preventing ulcers associated with the diabetic hammertoe deformity.
Diabetic foot complications is a collective term used for the ailments of the foot that individuals with diabetes incur. The different entities of the term diabetic foot complications are closely linked to each other and several of the other complications of diabetes. Despite implementation of national and international preventive guidelines, diabetic foot complications are still a growing challenge to the individual and society in general. This highlights the need for new strategies in the treatment and prevention of diabetic foot complications. The aim of the study was to investigate associations between plasma metabolites and diabetic foot complications (diabetic foot ulcer (DFU), amputations and Charcot’s Arthropathy) in individuals with diabetes type 1. Non targeted plasma metabolites (n=75) were analyzed using mass spectrometry in a cohort comprising 637 individuals (55% male) with diabetes type 1. Cross sectional associations between metabolites and diabetic foot complications was analysed by linear regression at baseline and by Cox proportional hazards model at follow-up and adjusted for relevant confounders. The median follow up time was 10 years, age 55 (47, 64) years, diabetes duration 35 (25, 44) years and HbA1c 64 (56, 72) mmol/mol. In the adjusted model, four amino acids (proline, threonine, valine, and leucine) were associated with decreased incidence of Charcot’s arthropathy at baseline (padjusted< 0.5). In addition, the plasma levels of ribonic acid was associated with an increased risk of diabetic foot ulcers during follow-up (HR 1.38(1.06-1.8) p<0.05). This study identifies novel circulating metabolites, as potential biomarkers for risk of diabetic foot complications.One Sentence SummarySeveral plasma metabolites show promise as risk markers of diabetic foot complications.
Aim The aim of this study was to investigate safety of treating diabetic foot ulcers with a topically administered mesenchymal stem cell product. Method Individuals with diabetes, peripheral neuropathy, toe blood pressure > 39 mmHg and non-infected foot ulcers with duration of four to fifty-two weeks were screened. Participants were treated with a one-time application of a topically applied allogeneic cellular product containing CD362 enriched mesenchymal stem cells suspended in a collagen solution. Participants were subsequently followed for seven months to gather information on adverse event and serious adverse events. Results/discussion A total of sixteen individuals were screened, of whom two were included. The included participants incurred a total of seven adverse events and one serious adverse event. Increased exudation from the treated diabetic foot ulcer was observed for both participants and a connection to investigational medicinal product was suspected. The increased exudation was resolved within one week after application of investigational medicinal product, without any further complications. The serious adverse event consisted of a hospital admission due to neurological symptoms, which were assumed to be caused by hypoglycemia, with no suspected correlation to the investigational medicinal product. None of the other observed adverse events were suspected to be associated with the investigational medicinal product. Conclusion This study presents data from two individuals with a diabetic foot ulcer treated with a novel topical mesenchymal stem cell product. An adverse event observed for both participants was suspected to be associated to the investigational medicinal product, i.e., increased exudation, which was resolved within one week, did not lead to further complications and can easily be remedied by choosing bandages with higher absorption capacity or increasing frequency of bandage changes. This study lays the groundwork for further large scale randomized clinical studies. Trial registration: EudraCT number 2015-005580-16. Registered 12/06-2018.
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