RT Journal Article
T1 Superiority of a Novel Multifunctional Amorphous Hydrogel Containing Olea europaea Leaf Extract (EHO-85) for the Treatment of Skin Ulcers: A Randomized, Active-Controlled Clinical Trial.
A1 Verdu-Soriano, Jose
A1 de Cristino-Espinar, Marisol
A1 Luna-Morales, Silvia
A1 Dios-Guerra, Caridad
A1 Caballero-Villarraso, Javier
A1 Moreno-Moreno, Paloma
A1 Casado-Diaz, Antonio
A1 Berenguer-Perez, Miriam
A1 Guler-Caamaño, Ipek
A1 Laosa-Zafra, Olga
A1 Rodriguez-Mañas, Leocadio
A1 Lazaro-Martinez, Jose Luis
K1 EHO-85
K1 Diabetic foot
K1 Pressure ulcer
K1 Randomized active-controlled trial
K1 Venous leg ulcer
AB 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 multidose 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 acceleratingwound healing and (ii) the superiority of a specific hydrogel over another.
PB MDPI
SN 2077-0383
YR 2022
FD 2022-02-25
LK http://hdl.handle.net/10668/21247
UL http://hdl.handle.net/10668/21247
LA en
NO Verdú-Soriano J, de Cristino-Espinar M, Luna-Morales S, Dios-Guerra C, Caballero-Villarraso J, Moreno-Moreno P, et al. Superiority of a Novel Multifunctional Amorphous Hydrogel Containing Olea europaea Leaf Extract (EHO-85) for the Treatment of Skin Ulcers: A Randomized, Active-Controlled Clinical Trial. J Clin Med. 2022 Feb 25;11(5):1260
DS RISalud
RD Apr 12, 2025