Predictive value of foot pressure assessment as part of a population-based diabetes disease management program

WSTĘP. Celem pracy była ocena przydatności dynamicznego pomiaru ciśnienia podeszwowego w identyfikacji grupy chorych wysokiego ryzyka powstawania owrzodzeń neuropatycznych. Wybierając punkt odcięcia, szukano optymalnej kombinacji swoistości i czułości wartości ciśnienia podeszwowego, pozwalającej ocenić ryzyko występowania owrzodzeń neuropatycznych. MATERIAŁ I METODY. Grupę 1666 chorych na cukrzycę (50,3% mężczyzn) kolejno zgłaszających się do dużego miejskiego centrum diabetologicznego zakwalifikowano do badania zaplanowanego na 2 lata. Podczas kwalifikacji pacjentów poddano standardowemu badaniu klinicznemu, ze szczególnym uwzględnieniem układu mięśniowo-szkieletowego, a także dokładnej ocenie w miejscowym gabinecie stopy cukrzycowej. WYNIKI. Z całej badanej populacji u 263 chorych (15,8%) owrzodzenie stóp występowało podczas badania wstępnego lub powstało w czasie 24-miesięcznej obserwacji. Jak oczekiwano, podstawowe maksymalne ciśnienie podeszwowe było znamiennie wyższe u osób z grupy z owrzodzeniami niż u osób z grupy bez tej zmiany (95,5 &plusmn; 26,4 vs. 85,1 &plusmn; 27,3 N/cm2, p < 0,001). Zaobserwowano również tendencję do związku wyższego ciśnienia podeszwowego z większą liczbą zniekształceń stopy, jak również z klasyfikacją do grupy wyższego ryzyka rozwoju owrzodzeń (p = 0,0001). Maksymalne ciśnienie podeszwowe nie było odpowiednim, samodzielnym narzędziem identyfikującym chorych z grupy wysokiego ryzyka. Przy zastosowaniu krzywej operacyjno-charakterystycznej (ROC, receiver operating characteristic), po wyłączeniu z analizy pacjentów z nieupośledzonym czuciem powierzchownym, optymalny punkt odcięcia wartości ciśnienia podeszwowego, określony na podstawie najlepszej kombinacji swoistości i czułości, wynosił 87,5 N/cm2, osiągając czułość 63,5% i swoistość 46,3%. WNIOSKI. Uzyskane dane potwierdzają, że podwyższone ciśnienie podeszwowe jest istotnym czynnikiem ryzyka powstawania zespołu stopy cukrzycowej, chociaż analiza ROC sugeruje, że ciśnienie to jako pojedynczy parametr jest słabym wskaźnikiem pozwalającym ocenić ryzyko powstawania owrzodzeń stóp.INTRODUCTION. To evaluate the effectiveness of dynamic plantar pressure assessment to determine patients at high risk for neuropathic ulceration. In choosing the cut point, we looked for an optimum combination of sensitivity and specificity of plantar pressure to screen for neuropathic ulceration. MATERIAL AND METHODS. A total of 1,666 consecutive individuals with diabetes (50.3% male) presenting to a large urban managed care &#8212; based outpatient clinic were enrolled in this longitudinal 2-year outcome study. Patients received a standardized medical and musculoskeletal assessment at the time of enrollment, including evaluation in an onsite gait laboratory. RESULTS. Of the entire population, 263 patients (15.8%) either presented with or developed an ulcer during the 24-month follow-up period. As expected, baseline peak plantar pressure was significantly higher in the ulcerated group than in the group who did not ulcerate (95.5 &plusmn; 26.4 vs 85.1 &plusmn; 27.3 N/cm2, P < 0.001). There was also a trend toward increased pressure with increasing numbers of foot deformities, as well as with increasing foot risk classification (P = 0.0001). Peak pressure was not a suitable diagnostic tool by itself to identify high-risk patients. After eliminating patients without loss of protective sensation, using receiver operating characteristic (ROC) analysis, the optimal cut point, as determined by a balance of sensitivity and specificity, was 87.5 N/cm2, yielding a sensitivity of 63.5% and a specificity of 46.3%. CONCLUSIONS. The data from this evaluation continue to support the notion that elevated foot pressure is an important risk factor for foot complications. However, the ROC analysis suggests that foot pressure is a poor tool by itself to predict foot ulcers

Efficacy and Safety of Antioxidant Treatment With α-Lipoic Acid Over 4 Years in Diabetic Polyneuropathy

Objective: To evaluate the efficacy and safety of α-lipoic acid (ALA) over 4 years in mild-to-moderate diabetic distal symmetric sensorimotor polyneuropathy (DSPN). Research Design and Methods: In a multicenter randomized double-blind parallel-group trial, 460 diabetic patients with mild-to-moderate DSPN were randomly assigned to oral treatment with 600 mg ALA once daily (n = 233) or placebo (n = 227) for 4 years. Primary end point was a composite score (Neuropathy Impairment Score [NIS]–Lower Limbs [NIS-LL] and seven neurophysiologic tests). Secondary outcome measures included NIS, NIS-LL, nerve conduction, and quantitative sensory tests (QSTs). Results: Change in primary end point from baseline to 4 years showed no significant difference between treatment groups (P = 0.105). Change from baseline was significantly better with ALA than placebo for NIS (P = 0.028), NIS-LL (P = 0.05), and NIS-LL muscular weakness subscore (P = 0.045). More patients showed a clinically meaningful improvement and fewer showed progression of NIS (P = 0.013) and NIS-LL (P = 0.025) with ALA than with placebo. Nerve conduction and QST results did not significantly worsen with placebo. Global assessment of treatment tolerability and discontinuations due to lack of tolerability did not differ between the groups. The rates of serious adverse events were higher on ALA (38.1%) than on placebo (28.0%). Conclusions: Four-year treatment with ALA in mild-to-moderate DSPN did not influence the primary composite end point but resulted in a clinically meaningful improvement and prevention of progression of neuropathic impairments and was well tolerated. Because the primary composite end point did not deteriorate significantly in placebo-treated subjects, secondary prevention of its progression by ALA according to the trial design was not feasible

Reduced Lower-Limb Muscle Strength and Volume in Patients With Type 2 Diabetes in Relation to Neuropathy, Intramuscular Fat, and Vitamin D Levels.

OBJECTIVE: Muscle weakness and atrophy of the lower limbs may develop in patients with diabetes, increasing their risk of falls. The underlying basis of these abnormalities has not been fully explained. The aim of this study was to objectively quantify muscle strength and size in patients with type 2 diabetes mellitus (T2DM) in relation to the severity of neuropathy, intramuscular noncontractile tissue (IMNCT), and vitamin D deficiency. RESEARCH DESIGN AND METHODS: Twenty patients with T2DM and 20 healthy control subjects were matched by age, sex, and BMI. Strength and size of knee extensor, flexor, and ankle plantar and dorsiflexor muscles were assessed in relation to the severity of diabetic sensorimotor polyneuropathy (DSPN), amount of IMNCT, and serum 25-hydroxy vitamin D (25OHD) levels. RESULTS: Compared with control subjects, patients with T2DM had significantly reduced knee extensor strength (P = 0.003) and reduced muscle volume of both knee extensors (P = 0.045) and flexors (P = 0.019). Ankle plantar flexor strength was also significantly reduced (P = 0.001) but without a reduction in ankle plantar flexor (P = 0.23) and dorsiflexor (P = 0.45) muscle volumes. IMNCT was significantly increased in the ankle plantar (P = 0.006) and dorsiflexors (P = 0.005). Patients with DSPN had significantly less knee extensor strength than those without (P = 0.02) but showed no difference in knee extensor volume (P = 0.38) and ankle plantar flexor strength (P = 0.21) or volume (P = 0.96). In patients with 25 nmol/L 25OHD, no significant differences were found for knee extensor strength and volume (P = 0.32 vs. 0.18) and ankle plantar flexors (P = 0.58 vs. 0.12). CONCLUSIONS: Patients with T2DM have a significant reduction in proximal and distal leg muscle strength and a proximal but not distal reduction in muscle volume possibly due to greater intramuscular fat accumulation in distal muscles. Proximal but not distal muscle strength is related to the severity of peripheral neuropathy but not IMNCT or 25OHD level

Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial

Introduction There are no well-established biomedical treatments for the core symptoms of autism spectrum disorder (ASD). A small number of studies suggest that repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, may improve clinical and cognitive outcomes in ASD. We describe here the protocol for a funded multicentre randomised controlled clinical trial to investigate whether a course of rTMS to the right temporoparietal junction (rTPJ), which has demonstrated abnormal brain activation in ASD, can improve social communication in adolescents and young adults with ASD. Methods and analysis This study will evaluate the safety and efficacy of a 4-week course of intermittent theta burst stimulation (iTBS, a variant of rTMS) in ASD. Participants meeting criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ASD (n=150, aged 14–40 years) will receive 20 sessions of either active iTBS (600 pulses) or sham iTBS (in which a sham coil mimics the sensation of iTBS, but no active stimulation is delivered) to the rTPJ. Participants will undergo a range of clinical, cognitive, epi/genetic, and neurophysiological assessments before and at multiple time points up to 6 months after iTBS. Safety will be assessed via a structured questionnaire and adverse event reporting. The study will be conducted from November 2020 to October 2024. Ethics and dissemination The study was approved by the Human Research Ethics Committee of Monash Health (Melbourne, Australia) under Australia’s National Mutual Acceptance scheme. The trial will be conducted according to Good Clinical Practice, and findings will be written up for scholarly publication. Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12620000890932)