A large Italian observational multicentre study on vascular ulcers of the lower limbs (Studio Ulcere Vascolari).

An observational study of 2 years was promoted by the Italian Association for Cutaneous Ulcers (AIUC) in order to monitor the epidemiology of leg ulcers, the trend of healing and the more frequent therapeutic approaches in lower limb ulcers. Fifty-nine sites in 14 different Italian regions involved in the study, with 1333 enrolled patients (1163 patients fully evaluated and followed up for 9 months). A prevalence of females (62%) was observed with a mean age of 70 years and a high rate of hypertension (62%), diabetes (38%) and obesity (29%). Venous ulcer was most frequent (55%), followed by mixed (25%) and diabetic (8·3%) ulcers. Basically, all patients received a local therapy (LT) (compression and advanced local therapies), while 63% of patients have an associated systemic pharmaceutical treatment. Ulcer healing rates progressively increased throughout the study and despite the type of observational study does not allow conclusions on the treatment, it was observed that the patients receiving additional systemic drugs were associated with a more rapid acceleration of healing rates of ulcers compared to LT alone (3 months: 39·7% versus 29·2%; 6 months: 62·0% versus 47·0%; 9 months: 74·7% versus 63·8%). In particular, the Studio Ulcere Vascolari (SUV) study showed that a combination treatment with sulodexide and compression therapy allows for a greater increase in the healing rates in venous ulcers.

The influence of aneurysm size on early outcome of abdominal aortic aneurysm repair in female patients.

AIM: The purpose of this study was to examine the influence of aneurysm size on early outcome in women undergoing abdominal aortic aneurysm (AAA) repair, with suggestion of lowered threshold for intervention. PATIENTS AND METHODS: Retrospective cohort study on the early outcome of 25 females undergoing elective endovascular (EVAR) and open AAA repair, compared to 340 males from 2005 to 2017. The study was focused on 30-days mortality (primary endpoint) and incidence of non fatal major adverse events - MAE (secondary endpoint) of two subgroups of women: AAA diameter <50 mm (n.14, group F1), AAA diameter ≥ 50mm (n.11, group F2). RESULTS: The incidence of the primary endpoint at 30 days was 4% in females, and 1.1% in males, respectively (p=ns). Similarly, females showed a higher rate of MAE compared to males (16% vs 9.4%, p=ns). Women who underwent surgery with small aneurysms (F1 group) had an early outcome similar to men (30-day death 0% vs 1.1%, p=ns; MAE 7.1% vs 9.4%, p=ns) and significantly better than women with larger aneurysms (30-day death 0% vs 9%, p=ns; MAE 7.1% vs 27.2, p=ns). CONCLUSIONS: Although poorly significant from a statistical point of view, the present report seems to confirm that the AAA diameter is a relevant marker of disease severity in women, assuming that repair at smaller size may be associated with less comorbidity and better outcome. KEY WORDS: Abdominal aortic aneurysm, Abdominal aortic aneurys open repair, Endovascular aortic aneurysm repair, Female gender.

Thymosin beta-4 and venous ulcers: clinical remarks on a European prospective, randomized study on safety, tolerability, and enhancement on healing.

The objective of this double-blind, placebo-controlled, dose-escalation study is to evaluate safety, tolerability, and enhancement on healing of thymosin beta-4 (Tbeta-4) administered topically in patients with venous ulcers. Three groups of patients, coming from 10 sites, 5 from Italy and 5 from Poland, will be enrolled sequentially. Twenty-four patients within each group will be randomized to Tbeta-4 or placebo in a 3:1 ratio and will be treated with increasing doses of Tbeta-4. When review safety data show no-dose-limiting adverse events, a new group will be enrolled. So, the study design comprehends 72 patients treated for 84 days and followed for 14 days at the end of treatment. Blood samples will be taken on day 0 and at the end of treatment visit to measure plasma levels of Tbeta-4. Every week each patient is visited and blood samples are taken for clinical chemistry, hematology, coagulation, and urinalysis. Each ulcer is treated with debridement, if necessary, and compression therapy with standard compression stockings class 2. Efficacy parameters are incidence of healing defined as the percentage of patients who have complete closure of the index ulcer at day 84 and, mean time to complete healing. Ulcer area will be calculated by digital planimetry and photographic analysis. The study is ongoing and a total of 21 patients have been enrolled so far in the first treatment group at the lower dose. Patients' compliance and motivated and well-trained teams seem to be the most suitable parameters of a successfully conducted study.

The venous ulcer and the superficial venous reflux.

The management of venous ulcers must take into account the many aspects of the pathology and, overall, the hemodynamic patterns of reflux and the clinical pictures correlated. The most frequent model is represented by a superficial venous reflux that may be successfully treated by surgery with a very high percentage of ulcer healing. Compared to compression therapy, surgery allows a minor percentage of recurrence. Sclerotherapy may represent a valid alternative. The meaning and the treatment of incompetent perforating veins is controversial, but the poor results of conservative treatment justify the disconnection of large perforators in addition to ablation of saphenous reflux.

The regenerative peptide thymosin ß4 accelerates the rate of dermal healing in preclinical animal models and in patients.

Chronic nonhealing cutaneous wounds are a worldwide problem with no agent able to promote healing. A naturally occurring, endogenous repair molecule, thymosin beta 4 (Tß4), has many biological activities that promote dermal repair. It is released by platelets at the site of injury and initiates the repair cascade. Tß4 accelerated dermal healing of full-thickness punch wounds in various animal models, including normal rats and mice, steroid-treated rats, diabetic mice, and aged mice. Furthermore, in two phase 2 clinical trials of stasis and pressure ulcers, it was found to accelerate healing by almost a month in those patients that did heal. Tß4 likely acts to repair and regenerate wounds by promoting cell migration and stem cell mobilization and differentiation, and by inhibiting inflammation, apoptosis, and infection. We conclude that Tß4 is a multifunctional regenerative peptide important in dermal repair.