The Potential Role for a Painless Enzymatic Debridement Gel in Wound Bed Preparation for Venous Leg Ulcers-A Dose Escalation Study

Abstract

Venous leg ulcers (VLUs) are painful wounds that require thorough debridement to optimise their chances of healing. We sought to assess the impact on debridement pain from the use of tarumase gel in a prospective Phase IIA open-label, multi-centre, dose escalation study and comparing this to historical pain scores derived from a review of surgical and mechanical debridement within similar chronic wound populations. With tarumase gel, no increase in pain over baseline was observed, irrespective of whether pain was assessed 15-30 min after administration or whether the gel had been resident on the wound for 48-72 h. At the highest concentration of tarumase tested [11 U/mL], all reported NRS scores were below 2.90 (categorised as slight pain) with small trends towards a reduction in the pain score from as early as the first application. By contrast, from previous literature, surgical and mechanical debridement, when used without anaesthesia, commonly resulted in pain scores in excess of 50 mm on 100 mm visual analogue scales (VAS), categorised as moderate to severe pain. Pain from surgical/mechanical debridement can be reduced by topical anaesthetic creams; however, this requires at least 30-60 min of application and subsequent removal prior to debridement, making it impractical to use in busy clinic facilities.

Keywords: enzymatic debridement; surgical debridement; venous leg ulcers; wound pain.

FIGURE 1

Flow‐chart showing exclusions.