This 8-week, multicenter, randomized, active-controlled, observer-blinded clinical trial was designed to demonstrate the accelerating effect on wound healing of the novel
Olea europaea leaf extract hydrogel (EHO-85) by comparing it to a widely used amorphous
hydrogel. Results showed that EHO-85 significantly accelerated wound healing, regardless of
ulcer etiology (pressure, venous leg or
diabetic foot) and prognosis, doubling the median
wound area reduction compared with a reference amorphous
hydrogel (79.4% vs. 39.7%; difference: −39.7%, 95% CI: −71.1 to −21.3%; p < 0.001). The intention-to-treat analysis was conducted on 195 patients from 23 Spanish health centers/nursing homes. This novel treatment balances the
ulcer microenvironment by modulating
reactive oxygen species and pH. These actions
complement the moistening and barrier functions inherent to amorphous
hydrogels, whilst also conferring EHO-85 its documented granulation formation and
pain relief properties. Furthermore, efficacy was achieved safely and in a cost-efficient manner due to its multi-dose format, which reduced the amount of product needed by 85.8% over 8 weeks compared to single-use
hydrogel. The present randomized controlled trial is a relevant milestone in evidence-based practice for being the first to demonstrate (i) the effectiveness of an amorphous
hydrogel in accelerating wound healing and (ii) the superiority of a specific
hydrogel over another.