Efficacy and Safety of Bioactive Glass S53P4 as a Treatment for Diabetic Foot Osteomyelitis.

Osteomyelitis represents a challenging condition in the diabetic foot with an associated high risk of major amputation. S53P4 Bioactive Glass (BG) has bacterial inhibiting properties on the market and indicated to be used in osteomyelitis. The objective of the study was to test the efficacy and safety of BG in treating diabetic foot osteomyelitis. This was an observational, retrospective, single-centre study involving subjects with diabetes affected by osteomyelitis of the foot who underwent surgical debridement from 01/2016 to 10/2018. Overall, 44 diabetic patients (14 [31.8%] female, aged 68.0 ± 10.2 years, diabetes duration 26.8 ± 11.9 years) were studied: 22 (50%) treated with surgical debridement and a local application of BG; 22 (50%) treated by means of surgical debridement. The primary outcome was the osteomyelitis resolution. Revascularization was performed before surgical procedure in 31 (70.5%) of patients. Systemic antibiotics were used in both groups. The osteomyelitis resolution rate was significantly higher in subjects treated with BG than in subjects treated with traditional procedure (18 [90%] vs 13 [61.9%], respectively p = .03). The odds of BG to reach osteomyelitis resolution was 5.54 times greater than for traditional treatment (odds ratio 5.54, 95% confidence interval 1.10-30.5). The use of BG was associated with an 81% lower probability to need additional antibiotic therapy compared to subjects treated with traditional procedure (odds ratio 0.19, 95% confidence interval 0.04-0.87). The debridement of osteomyelitis followed by application of BG could be an effective and safe option in the treatment of osteomyelitis of the diabetic foot.

Effectiveness, Safety, and Acceptance of an Interim Orthosis in Patients with Diabetes in the Immediate Postoperative Chopart Surgery.

Chopart amputation is the consequence of severe diabetes-related foot complications. A new interim orthosis allowing the patient a greater degree of mobility after Chopart surgery than currently used systems is now available. The aim of this study was to evaluate the effectiveness of the new orthosis compared with traditional treatment. Safety and level of patient acceptance of the device were also investigated. We performed a retrospective case-control observational study involving people with diabetes who underwent Chopart amputation between January 2016 and January 2018. The sample of subjects treated with the innovative orthosis was compared with consecutive patients, who were treated with traditional management. The main study outcomes include major amputation occurrence, ulcer recurrence, healing time, and patient acceptance of the orthosis. Patient satisfaction was evaluated using the Italian validated version of the Orthotic Prosthetic User's Survey (OPUS) questionnaire. Overall, 27 subjects were enrolled using the new device (mean age 68.7 ± 8.4 years, 70.4% males, mean diabetes duration 22.7 ± 15 years). Clinical baseline characteristics were comparable between the cases and the controls. There was no difference between the groups in the healed wound rate (81.5% vs 80.0% for cases and the control group, respectively, P = .53). The ulcer recurrence rate was higher in the control group compared with subjects using the new orthosis (62.5% vs 24.0%, respectively, P = .04). The use of the innovative orthosis was associated with an 81% lower probability to have ulcer recurrence (odds ratio 0.19, 95% confidence interval 0.04-1.04). No between groups difference was detected for a major amputation rate. The wound healing time was faster for cases compared with controls (160.4 ± 114.1 vs 256.5 ± 112.9 days, P = .05). No adverse events related to the use of the new orthosis were recorded. Patient acceptance of the new orthosis was high. This orthosis can be recommended as an efficient, safe, and well-accepted device after Chopart amputation.

Raised serum TSH levels in patients with morbid obesity: is it enough to diagnose subclinical hypothyroidism?

OBJECTIVE: Morbid obesity (body mass index (BMI)> or =40 kg/m(2)) is associated with thyroid function disturbances, with a high rate of subclinical hypothyroidism (SH) being the most consistently reported. We evaluated the circulating thyroid function parameters in morbid obese patients and related the results to the presence of circulating thyroid antibodies (Thyr-Ab). DESIGN AND METHODS: Morbid obese patients were consecutively enrolled (n=350). Two control groups were used: control group (CG)1, healthy normo-weight subjects (n=50); CG2, normo-weight patients with SH (n=56) matched for TSH with the obese patients with SH. Serum levels of free triiodothyronine (FT(3)), free thyroxine (FT(4)), TSH, antithyroglobulin antibodies, and antithyroperoxidase antibodies were measured in all patients. RESULTS: i) Compared with CG1, obese patients having thyroid function parameters in the normal range and negative Thyr-Ab showed significantly higher serum TSH and lower free thyroid hormones levels, but a similar FT(4)/FT(3) ratio; ii) SH was recorded in 13.7% obese patients; iii) compared with CG2, obese patients with untreated SH had a significantly lower rate of positive Thyr-Ab (32.1 vs 66.1%; P<0.005); iv) no gender prevalence was observed in SH obese patients with negative Thyr-Ab; and v) the comparison of the untreated SH patients (obese and normo-weight) with CG1 demonstrated that in SH obese subjects, unlike normo-weight SH patients, the FT(3) levels were significantly lower. This resulted in a normal FT(4)/FT(3) ratio in SH obese patients. CONCLUSION: Thyroid autoimmunity is not a major cause sustaining the high rate of SH in morbid obese patients. In these patients, the diagnosis of SH itself, as assessed by a raised TSH alone, appears questionable.