Autologous platelet lysate product versus placebo in patients with chronic leg ulcerations: A pilot study using a randomized, double-blind, placebo-controlled trial

The objective of the authors' study was to assess the ability of autologous platelet lysate factors to facilitate healing of chronic cutaneous ulcers. Twenty-six patients with chronic leg ulcers participated in this prospective, randomized, double-blind, placebo-controlled trial at the wound care center at a tertiary care institution. Fifteen patients received autologous platelet lysate product mixed with collagen (treatment group); 11 patients received platelet-poor plasma mixed with collagen (placebo group). Treatment was applied twice daily for 12 weeks. After a two-week washout period, patients whose ulcers had not healed were assigned to receive the other treatment for an additional 12 weeks. The principal end point was the occurrence of complete healing (100% epithelialization of the entire target ulcer) as assessed by ulcer photography and clinical examination. A secondary end point was the rate at which the wound healed. Demographic characteristics were similar in both groups. There was no significant difference between the treatment group and the placebo group as measured by area of the wounds and by the randomization strategy at baseline, Week 12 (end of the first treatment period), and Week 28 (end of the study period). The rate of healing was not significantly different between the treatment group and the placebo group. The median slope estimating the rate of healing over time was -0.79 for the treatment group and -0.84 for the placebo group. The addition of autologous platelet lysate product to collagen did not accelerate the rate of wound healing or significantly decrease wound size compared with platelet-poor plasma with collagen.