Efficacy and safety of a gauze pad containing hyaluronic acid in treatment of leg ulcers of venous or mixed origin: a double‐blind, randomised, controlled trial

Abstract

Topical hyaluronic acid (HA) is routinely used in the local treatment of chronic wounds, but few data have been reported to date. A 60-day double-blind, randomised, controlled superiority trial was designed to investigate the efficacy and safety of a gauze pad containing HA in local treatment of venous leg ulcers, compared with its neutral vehicle. The primary endpoint was the percentage of wound size reduction after 45 days. Totally 89 patients were included. At day 45, the percentage of ulcer surface reduction was significantly greater in the HA group (73 ± 4·6%) versus neutral vehicle group (46 ± 9·6%) (P = 0·011). The number of healed ulcers was significantly higher in the HA group at day 45 (31·1% versus 9·3% respectively) and day 60 (37·8% versus 16·3% respectively; P < 0·05). At day 30, pain intensity based on visual analogue scale was significantly lower in the HA group (12·4 mm ± 2·6 versus 22·8 mm ± 3·8; P = 0·026). Tolerance of both treatments was comparable in the two groups. HA gauze pad, in local treatment of venous leg ulcers, was significantly more effective than the neutral vehicle on wound size reduction, healed ulcers rate and pain management with a good safety profile.

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

“…Inhibition of MMPs could represent a possible therapeutic intervention to limit the progression of leg ulceration. In particular, some authors have documented the efficacy of glycosaminoglycans in patients with chronic ulcers of the lower limbs 28,29. The term “glycosaminoglycan” refers to a category of related molecules that share common biologic properties, including heparin, low-molecular-weight heparin, heparan sulfate, and mixed glycosaminoglycan formulations, such as sulodexide (SDX).…”

Hyaluronic acid covers in burn treatment: a systematic review

“…It was found that the reduction of the ulcer surface area was significantly higher in the intervention group (73 ± 4.6%) versus the control group (46 ± 9.6%) (P = 0.011). The number of healed ulcers in the intervention group was higher at day 45 (31% vs. 9%, respectively) and day 60 (37% vs. 16%, respectively) (P<0.05) (12) . Specifically in thermal injuries, a cohort study with 60 patients with partial thickness burns found an average reduction of 50% in the size of the wound in the first five follow up days of combined application of hyaluronic acid with zinc.…”

“…In local treatment of wounds, it is used in the form of cream, gel, or impregnated gauze to promote healing (12) . Burns are a peculiar group of wounds treated with hyaluronic acid.…”

Hyaluronan and cardiac regeneration

“…Indeed, most of these studies underlined the benefits that the HA derivatives, either as hydrogel or solid mesh, exerted in human diseases such as venous ulcers [107],[108], decubitus ulcers [109], oral mucosal lesions [110], surgical ablation of nevi/cutaneous tumors and cicatritial outcomes [111], talar dome and knee osteochondral lesions [112],[113], and cranial bone regeneration [114]. So far, no clinical trial started to verify whether such biomaterial can be useful also to repair the infarcted myocardium.…”