The use of acellular porcine dermis, hyaluronic acid and polynucleotides in the treatment of cutaneous ulcers: Single blind randomised clinical trial.

Reconstruction of chronic ulcers is often hampered by lack of local tissues and poor general conditions. Conservative approaches with debridement and advanced medications, such as polyurethane foam, stand as mainstays. However, the healing process is often slow, thus increasing the risk for infection or other complications. In such cases, porcine dermis (PD) and polynucleotides-added hyaluronic acid (PAHA) were previously reported to accelerate healing. The aim of the study was to compare the efficacy of PD, PAHA and polyurethane foam in chronic ulcers. Thirty patients were randomly divided into 3 groups: group 1 was treated with advanced medications, group 2 with PD, group 3 with PAHA. Standardised photographs and biopsies were taken before treatment and at 30-day follow-up. Photographs were processed to calculate the wound area. Specimens were stained with Haematoxylin/Eosin, Masson trichrome, and immunohistochemically for CD34, alpha-Smooth Muscle Actin (α-SMA), Collagen types I and III, Ki67. The re-epithelialized area was larger in patients treated with PD and PAHA compared with those treated with polyurethane foam (P < .05 and P < .01, respectively). Specimens from patients treated with PD and PAHA showed a higher number of myofibroblasts (α-SMA+, P < .01), neo-angiogenesis (CD34+, P < .01), proliferating dermal cells (Ki67+, P < .01), proliferating keratinocytes (Ki67+, P < .01) and collagen type 1 deposition (P < .05). No difference was found between PD and PAHA. PD and PAHA proved to be more effective than polyurethane foam in the treatment of chronic ulcers. These approaches are a versatile and reliable option to address such cases.

The effects of sulodexide on both clinical and molecular parameters in patients with mixed arterial and venous ulcers of lower limbs.

BACKGROUND: Mixed venous and arterial ulcers account for approximately 15%-30% of all venous leg ulcerations. Several studies have shown that matrix metalloproteinases (MMPs) and neutrophil gelatinase-associated lipocalin (NGAL) play a central role in the pathophysiology of venous and arterial diseases. Some studies have shown the efficacy of glycosaminoglycans, such as sulodexide (SDX), in treating patients with leg ulcers. The aim of this study was to evaluate clinical effects of SDX and its correlation with MMPs and NGAL expression in patients with mixed arterial and venous leg ulcers. METHODS: Patients eligible for this study were of both sexes, older than 20 years, and with a clinical and instrumental diagnosis of mixed ulcer. RESULTS: Fifty-three patients of both sexes were enrolled and divided into two groups by means of randomization tables. Group A (treated group) comprised 18 females and ten males (median age: 68.7 years) treated with standard treatment (compression therapy and surgery) + SDX (600 lipoprotein lipase-releasing units/day intramuscularly) for 15 days followed by SDX 250 lipase-releasing units every 12 hours day orally for 6 months as adjunctive treatment. Group B (control group) comprised 17 females and eight males (median age: 64.2 years) treated with standard treatment only (compression therapy and surgery). The type of surgery was chosen according to anatomical level of vein incompetence: superficial venous open surgery and/or subfascial endoscopic perforating surgery. In all enrolled patients, blood samples were collected in order to evaluate the plasma levels of MMPs and NGAL through enzyme-linked immunosorbent assay. These results were compared to another control group (Group C) of healthy individuals. Moreover, biopsies of ulcers were taken to evaluate the tissue expression of MMPs and NGAL through Western blot analysis. Our results revealed that SDX treatment is able to reduce both plasma levels and tissue expression of MMPs improving the clinical conditions in patients with mixed ulcers. CONCLUSION: Inhibition of MMPs could represent a possible therapeutic intervention to limit the progression of leg ulceration. In particular, our findings demonstrate the efficacy of SDX in patients with mixed arterial and venous chronic ulcers of the lower limbs.