The effect of insulin and sulodexide (Vessel Due F) on diabetic foot syndrome. Pilot study in elderly patients

Celem pracy była ocena skuteczności stosowania insuliny wraz z sulodeksydem (mieszanina 80% pochodnych heparyny i 20% siarczanu dermatanu) w leczeniu owrzodzeń stóp oraz określenie ich wpływu na mikrokrążenie skórne i neuropatię cukrzycową. Chorzy z zaawansowaną neuropatią cukrzycową i owrzodzeniem stopy losowo przydzielono do grupy leczonej insuliną (I) z sulodeksydem (S) (n = 12) lub do grupy kontrolnej leczonej insuliną z placebo (P) (n = 6) przez 10 tygodni. Za pomocą metody dopplerowskiego lasera oceniano skórny przepływ krwi w stopach (LDF, laser doppler flow) w spoczynku oraz po 30- i 60-sekundowym niedokrwieniu. Ocenie poddano również przewodnictwo nerwowe na podstawie czuciowych i ruchowych potencjałów wywołanych. U chorych na cukrzycę skórny przepływ po niedokrwieniu był 2,5 raza krótszy w kończynie z owrzodzeniem niż w stopie zdrowej. Obserwowano znamienny wzrost przepływów skórnych po 30- i 60-sekundowym niedokrwieniu po zakończeniu terapii (grupa IS, owrzodzenie stopy, LDF - 60 s; od 99,1 &plusmn; 14,3 do 218,6 &plusmn; 28,6 PU, p < 0,001, grupa od 110,5 &plusmn; 13,0 do 164,8 &plusmn; 15,4 PU, p < 0,05). Czas przekrwienia reaktywnego uległ wydłużeniu w grupie IS (IS: od 30,3 &plusmn; 2,9 do 43,9 &plusmn; 2,2 s, p < 0,001; IP: od 28,7 &plusmn; 3,0 do 33,3 &plusmn; 3,3 s, NS). W grupie IS 92% owrzodzeń stóp uległo zagojeniu w ciągu 46,4 dnia, natomiast w grupie IP 83% w ciągu 63,0 dnia. Badania przewodnictwa nerwowego nie wykazały różnic nasilenia neuropatii w obrębie grup i pomiędzy grupami. W stopach z owrzodzeniami sulodeksyd i insulina poprawiają przepływ skórny w odpowiedzi na niedokrwienie, nie wpływając na przewodnictwo nerwowe. Kliniczne efekty działania sulodeksydu, sumując się z działaniami insuliny, mogą istotnie skracać czas niezbędny do całkowitego wyleczenia owrzodzenia. Ostateczne potwierdzenie przedstawionych wstępnych wyników wymaga dalszych badań klinicznych.To assess the efficacy of insulin plus sulodexide (a mixture of 80% heparin-like substances and 20% dermatan sulphate) on diabetic ulcers, and its influence on foot skin microcirculation and diabetic neuropathy. Two groups of diabetic patients, suffering from severe neuropathy and ulceration, were randomly assigned to insulin (I) plus sulodexide (S) (n = 12) or insulin plus placebo (P) (n = 6) therapy, for 10 weeks. Laser Doppler assessment of foot skin flow (LDF), at rest and 30 or 60 s after arterial occlusion, and nerve conduction tests (sensorial evoked and motoric conduction potentials) have been evaluated in both groups. Postischaemic flow was 2.5 times shorter in ulcerated vs. non-ulcerated feet in diabetic patients. A significant increase in flows after 30 and 60 s ischaemia was detected in both groups at the end of therapy (IS group, ulcerated foot, LDF = 60 s: from 99.1 &#177; 14.3 to 218.6 &#177; 28.6 PU, P < 0.001. IP group = from 110.5 &#177; 13.0 to 164.8 &#177; 15.4 PU, P < 0.05). The length of reactive hyperaemia was higher in IS vs. IP group (IS: from 30.3 &#177; 2.9 to 43.9 &#177; 2.2 s, P < 0.001; IP: from 28.7 &#177; 3.0 to 33.3 &#177; 3.3 s, ns). Ninety-two percent of ulcers heals in a mean time of 46.4 days (IS group) vs. 83% and 63.0 days, respectively, in IP group. Nerve conduction studies have not demonstrated within- and between-group differences. Sulodexide and insulin improve the postischaemic skin flow in ulcerated feet, without affecting nerve conduction tests. The effect of sulodexide results additive to insulin; it is clinically relevant, in the view of the possibility of reducing the time needed to completely heal ulcers. The ultimate validation of these preliminary results requires extensive trials

Relationship between the Clinical Frailty Scale and short-term mortality in patients ≥ 80 years old acutely admitted to the ICU: a prospective cohort study.

BACKGROUND: The Clinical Frailty Scale (CFS) is frequently used to measure frailty in critically ill adults. There is wide variation in the approach to analysing the relationship between the CFS score and mortality after admission to the ICU. This study aimed to evaluate the influence of modelling approach on the association between the CFS score and short-term mortality and quantify the prognostic value of frailty in this context. METHODS: We analysed data from two multicentre prospective cohort studies which enrolled intensive care unit patients ≥ 80 years old in 26 countries. The primary outcome was mortality within 30-days from admission to the ICU. Logistic regression models for both ICU and 30-day mortality included the CFS score as either a categorical, continuous or dichotomous variable and were adjusted for patient's age, sex, reason for admission to the ICU, and admission Sequential Organ Failure Assessment score. RESULTS: The median age in the sample of 7487 consecutive patients was 84 years (IQR 81-87). The highest fraction of new prognostic information from frailty in the context of 30-day mortality was observed when the CFS score was treated as either a categorical variable using all original levels of frailty or a nonlinear continuous variable and was equal to 9% using these modelling approaches (p < 0.001). The relationship between the CFS score and mortality was nonlinear (p < 0.01). CONCLUSION: Knowledge about a patient's frailty status adds a substantial amount of new prognostic information at the moment of admission to the ICU. Arbitrary simplification of the CFS score into fewer groups than originally intended leads to a loss of information and should be avoided. Trial registration NCT03134807 (VIP1), NCT03370692 (VIP2)