Section's osseous slice biopsy during major amputation of lower extremity: preliminary results of prospective cohort study.

BACKGROUND: The purpose of this cohort study was to assess the incidence of positive cultures in section's osseous slice biopsy (SOB) taken at the level of major limb amputation. In case of positive cultures we sought whether the microorganisms present in SOB could take origin from the primary infection site necessitating the amputation. The impact of diabetes on culture results was also investigated. METHODS: This prospective cohort study, which aimed to confirm the results of the pilot study, analysed patients who underwent major limb amputation between 2012 and 2013 in three Lithuanian hospitals. SOBs at the amputation site (surgical bone biopsies) and percutaneous bone biopsies of the distal site were performed simultaneously during limb amputation. Tissue cultures were analysed by microbiologists, and species along with antibiograms were reported. Histopathological assessment and bacterial typing were also evaluated. A positive culture was defined as the identification of at least 1 bacteria not belonging to the skin flora, at least 2 bacteria belonging to the skin flora with the same antibiotic susceptibility profiles or the same bacteria belonging to the skin flora in two different sites. Fisher's exact test and Student's test were used to compare the populations and the microbiological results. The statistical significance level was set at P < 0.05. RESULTS: Sixty-nine patients (35 males/34 females), mean age 68.7 (S = 13.6) years, including 21 (30.4%) with diabetes underwent the major limb amputation. Forty-five amputations (65.2%) were done above the knee. In total, 207 SOBs and 207 percutaneous distal site biopsies were studied. SOB cultures were positive in 11 (15.9%) cases. In 5 (45.5%) cases the same microorganisms were identified in both SOB and distal biopsy cultures. No association between culture results and presence of diabetes was identified. CONCLUSIONS: Our results suggest that, independently of the diabetes status, foot infection may silently spread along the bone and can achieve the site of major limb amputation. Additional investigations aiming to confirm this hypothesis and to evaluate a prognostic value are in progress.

Adequate prescribing of medication does not necessarily translate into good control of diabetes mellitus.

BACKGROUND: Patients with diabetes mellitus in Lithuania have access to almost all the latest blood glucose-lowering drugs available in the rest of the world. This study evaluated the effects of prescribing of treatment (oral medications, insulin, or both) in Lithuanian patients with type 1 or 2 diabetes and poor blood glucose control. METHODS: The relevant information was obtained from specialized questionnaires completed by 26 consulting endocrinologists in Lithuania between October 1, 2008 and December 31, 2008. The study cohort comprised 865 randomly selected patients with diabetes mellitus and a glycosylated (HbA1c) level ≥7%. In total, there were 95 patients with type 1 diabetes and 770 with type 2 diabetes. RESULTS: Linear regression for patients with type 1 diabetes revealed a weak trend towards higher doses of insulin reflecting lower HbA1c values. The mean dose of insulin in patients with type 1 diabetes before an endocrinology consultation was 57.1 ± 15.7 U/day (0.8 ± 0.2 U/kg), which increased significantly to 63.3 ± 16.5 U/day (0.9 ± 0.2 U/kg) after an endocrinology consultation (P < 0.05). Treatment prescribed for patients with type 2 diabetes depended on the duration of disease. Earlier treatment recommended for 68% of patients with type 2 diabetes was subsequently changed by the endocrinologist. Linear regression showed that the insulin dose prescribed before a specialist consultation as well as that recommended by an endocrinologist was significantly correlated with body mass index. CONCLUSION: Appropriate prescribing of blood glucose-lowering drugs does not always translate into good metabolic control of diabetes mellitus. The mean HbA1c was 8.5% ± 1.3% in patients with type 2 diabetes treated with oral drugs alone versus 9.0% ± 1.3% in those treated with insulin alone.

Importance of pain evaluation for more accurate diagnosis of painful diabetic polyneuropathy.

UNLABELLED: Pain is a common problem in diabetic neuropathy, but relatively little has been published regarding the extent to which it needs to be addressed in clinical practice. OBJECTIVE: To assess neuropathic pain profile and its association with quantitative sensory testing in painful diabetic polyneuropathy. MATERIAL AND METHODS: Altogether, 61 consecutive diabetic inpatients with symmetric neuropathic complaints were enrolled. Clinical neurological examination and quantitative sensory testing (QST) were performed. Patients were interviewed using the Neuropathic Pain Scale (NPS) and filled in the McGill Pain Questionnaire (MPQ). RESULTS: Of all patients, 49 (80.3%) had clinical diabetic polyneuropathy. Only 17 of these patients complained of lower extremity pain on an initial interview, while 27 marked it in the MPQ. The intensity of deep and superficial pain did not differ, but patients rated deep pain as more unpleasant than superficial (6.27±2.37 vs. 4.30±1.42 on the NPS, P=0.034). Superficial pain NPS items tended to correlate with QST results, while deep pain items did not. Only female gender (OR=7.87) and lower glycosylated hemoglobin level (OR=0.65) were predictive of pain in case of diabetic neuropathy. CONCLUSIONS: Standard pain questionnaires were useful in identifying pain sufferers. At the same intensity, deep neuropathic pain was more unpleasant than superficial. Pain manifestation was associated with female gender and lower level of glycosylated hemoglobin.

Reducing wound pain in venous leg ulcers with Biatain Ibu: a randomized, controlled double-blind clinical investigation on the performance and safety.

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p<0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p<0.001). At day 43-47, the patients in the ibuprofen-foam group had a significant (p<0.05) reemergence of persistent pain and pain at dressing change (p<0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low-dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.

Less pain with Biatain-Ibu: initial findings from a randomised, controlled, double-blind clinical investigation on painful venous leg ulcers.

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicentre, randomised, double-blind clinical investigation of 122 patients compared two moist wound-healing dressings, a non adhesive foam dressing with ibuprofen (62 patients randomised to Biatain-Ibu non adhesive, Coloplast A/S) with a non adhesive foam without ibuprofen (60 to Biatain non adhesive). The ibuprofen-foam was regarded successful, if the pain relief on a 5-point verbal rating scale was higher than the comparator without compromising safety, including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 and days 43-47. The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group compared with the comparator on days 1-5, with a quick onset of action (P < 0.05). The patients in the ibuprofen-foam group had a significant (P < 0.05) higher reduction in the persistent wound pain from baseline (40%) as the comparator (30%). Women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with increasing initial pain intensity and increasing wound size. Wound healing was similar in the ibuprofen-foam group to that of the comparator group. No difference in adverse events between placebo and local sustained release of low-dose ibuprofen was observed in this study. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters. The full report of this study will be published in Wound Repair and Regeneration.

[The economic estimates of well-timed diagnostics and early treatment of type 2 diabetes mellitus]. / Laiku diagnozuoto 2 tipo cukrinio diabeto ir anksti pradeto gydymo ekonominis ivertinimas.

UNLABELLED: Type 2 diabetes mellitus is a severe, high-priced, and to date not curable, however, controllable disease. When diabetes mellitus is not treated or is poorly controlled, complications of small and large blood vessels arise, and the mortality increases. The costs of treatment of diabetes-related complications are very high. Estimates performed in other countries show that expenses on treatment of diabetes-related complications are considerably higher than the expenses paid for diabetes control itself. Type 2 diabetes mellitus is often diagnosed too late, when complications requiring expensive treatment are already present. OBJECTIVE: The aim of the study was to estimate the impact of well-timed diagnostics and early treatment of type 2 diabetes mellitus on total health care costs. METHODS: Direct and indirect costs of treatment of the disease and its complications were estimated using Markov model with a discount of 5% per annum. RESULTS: It was calculated that with well-timed diagnostics and early initiation of treatment of type 2 diabetes mellitus the total costs to budget of the Compulsory Health Insurance Fund per one patient would be reduced by 1,736 Lt over 5 years and over 10 years our state would save 5,911 Lt. Not only direct but indirect costs would be reduced as well. The costs of 2,418 Lt would be saved per one patient over 5 years, and 7,061 Lt - over 10 years. With improvement of diagnostics of type 2 diabetes mellitus and with well-timed diagnostics in at least 50% of cases of diabetes mellitus in Lithuania, the health budget could save 34.7 million Lt over 5 years, and even 118.2 million Lt over 10 years. Diagnosis of type 2 diabetes mellitus made in time and administration of reimbursed drugs would prolong the life of a patient with type 2 diabetes mellitus by 2.67 months over 10 years. CONCLUSION: Diagnosis of type 2 diabetes mellitus in time provides a possibility to reduce expenses of diabetes treatment and care and to prolong a patient's life.