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.

Treatment of thyroid-associated orbitopathy with rituximab--a novel therapy for an old disease: case report and literature review.

OBJECTIVE: To report the use of rituximab to treat thyroid-associated orbitopathy (TAO) in a patient with a concomitant B-cell organ-specific autoimmune disorder-the stiff person syndrome (SPS). METHODS: We present a case report and a review of the related literature. RESULTS: A 62-year-old man with SPS, latent autoimmune diabetes of the adult, and Graves-Basedow disease was referred to our medical center because of bilateral TAO. An ophthalmologic examination documented asymmetric bilateral NOSPECS (N = no signs or symptoms; O = only signs, no symptoms; S = soft tissue involvement; P = proptosis; E = extraocular muscle involvement; C = corneal involvement; and S = sight loss) class IV TAO (left eye>right eye) with a clinical activity score of 5 on a scale of 7. Magnetic resonance imaging of the orbits documented bilateral exophthalmos (left eye>right eye) due to retrobulbar fibroadipose infiltration, bilateral increase of extrinsic ocular muscle thickness, and enhancement of the left inferior rectus muscle on T2-weighted sequences. Because of concomitant incapacitating SPS and diet-controlled latent autoimmune diabetes of the adult, we excluded long-term corticosteroid therapy as an option and considered the use of rituximab, a mouse-human chimeric monoclonal antibody targeting the CD20 protein on pre-B and mature B lymphocytes. Rituximab was administered in accordance with the protocol for rheumatoid arthritis. During the subsequent 4 months, clinical signs and symptoms of TAO dramatically resolved (clinical activity score = 0 of 7) with a sustained improvement of the spastic paraparesis. The glutamic acid decarboxylase antibody titer remained high, and glycemic control and first-phase insulin secretion did not change. CONCLUSION: Treatment of active TAO with rituximab should be considered when standard intravenous pulse glucocorticoid treatment is contraindicated or ineffective and when SPS or other organ-specific autoimmune disorders with involvement of humoral autoimmunity are present, inasmuch as more than 1 disease may benefit from the use of this chimeric monoclonal antibody.

Long-term effects of growth hormone replacement therapy on thyroid function in adults with growth hormone deficiency.

BACKGROUND: Clinical studies on the effect of growth hormone (GH) on thyroid function in patients with GH deficiency are contradictory. Further, the majority of published observations are limited to the first 6-12 months of GH replacement therapy. The aim of our study was to estimate the incidence of clinically relevant hypothyroidism in a cohort of patients with adult GH deficiency (AGHD) during long-term therapy with recombinant human GH (rhGH). METHODS: The study was designed as a retrospective collection of data on thyroid function in 49 AGHD patients of whom 44 (90%) had multiple hormone deficiency. Thirty-seven patients (76%) were on stable levothyroxine (LT4) replacement therapy (HYPO), and 12 (24%) were euthyroid (EUT). Therapy with rhGH was started at a dose of 3.5 microg/kg body weight and adjusted according to insulin-like growth factor-I (IGF-I) levels. At baseline, 6 months, 12 months, and yearly thereafter we measured free triiodothyronine (fT3), free thyroxine (fT4), thyroid-stimulating hormone, and IGF-I. Study outcome was fT4 level below the normal range (9 pmol/L), irrespectively of fT3 or thyroid-stimulating hormone levels. RESULTS: During a follow-up of 115 patient-years, mean fT4 level decreased significantly, although remaining within the normal range (p = 0.0242; month 48 vs. baseline). The largest decrease was between baseline and month 6, when fT4 decreased of 1.43 pmol/L (95% confidence interval, 0.33-2.53) per 1 unit (microg/kg body weight) increase in rhGH dose. The incidence of hypothyroidism was 1.2 (HYPO group) and 6.7 (EUT group) events per 100 patient-years. CONCLUSION: We confirm that in patients with AGHD, rhGH therapy is associated with a small, although significant, decrement of fT4 in the first 6 months of replacement therapy. However, the incidence of hypothyroidism is low. Monitoring of thyroid function during rhGH therapy is advisable, particularly in the first year of therapy when the largest decrease in fT4 occurs.