Journal
JOURNAL OF CLINICAL MEDICINE
Volume 11, Issue 5, Pages -Publisher
MDPI
DOI: 10.3390/jcm11051260
Keywords
diabetic foot; EHO-85; pressure ulcer; randomized active-controlled trial; venous leg ulcer
Categories
Funding
- QUESPER R&D (Cordoba, Spain)
- programme for Reinforcement of Research Activity in Clinical Management Units of Andalusian Health Service (Department of Health, Regional Government of Andalusia, Spain)
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This 8-week clinical trial compared the novel Olea europaea leaf extract hydrogel (EHO-85) with a commonly used amorphous hydrogel in terms of accelerating wound healing. The results showed that EHO-85 significantly accelerated wound healing, doubling the median wound area reduction compared to the reference hydrogel.
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.
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