Volume 27 Number 2

Key messages

• EHO-85, combining antioxidant, moisturising and protective properties, has demonstrated clinical value in improving advanced stages of pressure injuries (PI). The study aimed to evaluate the safety and efficacy of EHO-85 in the management of Stage 1 PI, compared with a standard hyper-oxygenated fatty acid formulation.
• EHO-85 significantly improved patient-reported quality of life and reduced discomfort earlier than the comparator, with both treatments improving lesion status and no adverse events reported.
• EHO-85 emerges as a promising option for early PI management, providing rapid symptomatic relief and offering potential benefits in broader chronic wound care contexts.

Introduction

Pressure injuries (PIs), formerly known as pressure ulcers or bedsores, are localised injuries to the skin and underlying tissue, typically occurring over bony prominences and/or in connection with medical devices due to prolonged mechanical forces (pressure, friction and shearing) and extrinsic and intrinsic factors that contribute to a decrease in tissue tolerance to these forces.^1-3

A valuable advance in skin care in the early stages of PIs is the use of oils derived from hyperoxygenated fatty acids (HOFA), which have demonstrated effectiveness in maintaining skin integrity and preventing the formation of PIs or delaying their onset.^16-21 As an alternative, EHO-85 has emerged as a class IIa medical device, multifunctional amorphous hydrogel, which has shown potential as a skin-protective and wound-healing agent.^22-24 It combines moisturising agents, a protective barrier polymer and Olea europaea leaf extract (OELE), known for its antioxidant and anti-inflammatory properties. Together, these components are designed to support skin repair by reducing oxidative stress, promoting moisture retention, balancing pH and creating a favorable wound microenvironment.²² OELE has demonstrated strong free radical scavenging activity, which may help reverse the oxidative imbalance that contributes to chronic or non-healing wounds.^{25, 26} The slightly acidic and semi-occlusive nature of EHO-85 further enhances conditions for tissue protection and recovery.²² The EHO-85 amorphous hydrogel has proven its efficacy and safety in the treatment of advanced stages of PI, venous leg ulcers (VLU), or diabetic foot ulcers (DFU) and annal fissures. It is therefore hypothesised that it could be a useful alternative in the treatment of Stage 1 PIs.^{23, 27-29}

They can develop in people of any age but are especially common in the elderly, subjects with limited mobility, such as those recovering from surgery or living with neurological conditions.⁴ These wounds remain a major issue in both hospital and long-term care environments, with prevalence rates ranging from 14% of hospital patients and up to 46% of aged care residents.^{1, 5} underscoring both their clinical impact and the pressing need for effective early prevention strategies.⁶ Clinically, PIs are staged by severity of skin damage. Stage 1 involves a non-blanchable erythema without skin breakage. Stage 2 shows partial skin loss, often resembling a blister or abrasion. In Stage 3, the damage extends deeper, possibly exposing fat tissue. Stage 4 is the most serious, with visible muscle, bone or tendon. There are also unstageable injuries, where dead tissue blocks full assessment, and cases of suspected deep tissue injury where the skin surface appears intact but darkened.^{7, 8}

Stage 1 PIs are the most common and represent the first indication that skin integrity has been compromised.⁹ Beyond the physical wound, PIs often cause pain, reduce quality of life (QoL), lead to longer hospital stays, and, overall, increase healthcare costs. Timely intervention in the Stage 1 PIs is critical to prevent these outcomes.^6,9 Treatment and prevention rely on a mix of clinical strategies, including frequent repositioning, the use of pressure-distributing surfaces, maintaining adequate nutrition, and consistent skin care.¹⁰ Protective skincare plays a central role, particularly in fragile or aging skin.^11-13 Moisturisers, emollients and barrier products are particularly relevant for aging or compromised skin, where reduced lipid content and water retention increase vulnerability to breakdown. This has led to growing interest in alternatives that go beyond protection and actively support the skin’s recovery process.^13,14 However, evidence supporting their effectiveness, especially in halting the early progression of PIs, remains limited and somewhat inconsistent.¹⁵

A valuable advance in skin care in the early stages of PIs is the use of oils derived from hyperoxygenated fatty acids (HOFA), which have demonstrated effectiveness in maintaining skin integrity and preventing the formation of PIs or delaying their onset.^16-21 As an alternative, EHO-85 has emerged as a class IIa medical device, multifunctional amorphous hydrogel, which has shown potential as a skin-protective and wound-healing agent.^22-24 It combines moisturising agents, a protective barrier polymer, and Olea europaea leaf extract (OELE), known for its antioxidant and anti-inflammatory properties. Together, these components are designed to support skin repair by reducing oxidative stress, promoting moisture retention, balancing pH  and creating a favorable wound microenvironment.²² OELE has demonstrated strong free radical scavenging activity, which may help reverse the oxidative imbalance that contributes to chronic or non-healing wounds.^25,26 The slightly acidic and semi-occlusive nature of EHO-85 further enhances conditions for tissue protection and recovery.²² The EHO-85 amorphous hydrogel has proven its efficacy and safety in the treatment of advanced stages of PI, venous leg ulcers (VLU), diabetic foot ulcers (DFU) and annal fissures. It is therefore hypothesised that it could be a useful alternative in the treatment of Stage 1 PIs.^23,27-29

The main aim of this multicenter clinical study was to assess whether treatment with EHO-85 represents a feasible and effective approach for managing early-stage PIs. The primary objective was to compare the clinical efficacy of EHO-85 versus a widely used HOFA formulation in reducing the visible symptoms of Stage 1 PIs, reducing discomfort levels and improving patients’ QoL. In addition to the effectiveness of EHO-85, the trial evaluated its safety throughout the treatment period by monitoring adverse events (AE) and treatment tolerability.

Methods

Study design

The study had a prospective, open-label multicenter, parallel-group design, with the aim of evaluating the efficacy of EHO‑85 compared to a HOFA emulsion that has been used widely in clinical practice for many years in the early stages of PIs . Patients were recruited from three centers: The SyncroMD Medical Center and the AIDE-SANTE SRL Medical Center in Romania, and the Medical Center Prolet in Bulgaria. Subjects were screened and enrolled by physicians at their individual medical offices and/or medical centers.

Enrollment followed predefined inclusion and exclusion criteria. Eligible participants were adults over 18 years of age, clinically diagnosed with Stage 1 PIs defined as non-blanchable erythema over intact skin.⁷ To be included, subjects had to provide signed informed consent and agree to comply with all study procedures, including attendance and participation at all scheduled visits and assessments. Patients were excluded if they had a history of drug or alcohol abuse, a medical history of peripheral artery disease, or known hypersensitivity to any component of the study product. Additional exclusion criteria included participation in another investigational study within the month prior to enrollment, pregnancy or breastfeeding, existing dermatological conditions affecting the study area, or chronic skin pathologies that could interfere with assessment.

The enrolment was competitive, and subjects were allocated in a 1:1 ratio to receive either EHO-85 or a widely used HOFA formulation as comparator treatment (CT). The EHO‑85 is composed of purified water, OELE, Carbopol 980®, trieathanolamine, disodic ethylenediaminetetraacetic acid (EDTA), Geogard ultra®, glycerin and Fucocert®. Corpitol® is a topical oil composed of hyperoxygenated glycerides of essential fatty acids (linolenic, linoleic 60%, palmitic, and stearic), and tocopherol (Vitamin E).

A minimum sample size of 44 participants (at least 20 subjects per arm) was calculated to detect a 39% difference in injury resolution between groups, assuming a 5% significance level, 80% statistical power, and accounting for an anticipated dropout rate of 10%. Participant recruitment took place over a six-month period, and each subject was followed for 45 days.

Ethical approval was obtained from the Local Ethics Committee for Clinical Trials of SC Syncro Clinical Research SRL in Romania (77/15.01.2024) and from the Local Ethics Committee at Medical Centre Prolet LTD in Bulgaria (000000026/19.04.2024) and registered in the public database International Standard Randomised Controlled Trial Number: ISRCTN13554350. The trial was undertaken in accordance with the ISO 14155 Standard ‘Clinical investigation of medical devices for human subjects – Good clinical practice’ and the Declaration of Helsinki. All participants provided written informed consent.

Intervention

Participants were assigned to receive either EHO-85 as the experimental group, or HOFA as the CT, as it is routinely used for the prevention and treatment early stages of PIs.^17,30 Treatment was applied topically, as advised by the investigator or designated member of staff, for an initial period of two weeks, after which patients were evaluated regarding the risk of PIs progression using the Braden Scale.^31,32 In cases where the Braden Scale score indicated a mild-to-high risk of PI progression (score ≤15)^33,34 product administration continued for an additional month, as determined by the investigator. Participants were instructed to store the product at temperatures below 25°C and to avoid freezing. Product administration and compliance were monitored by the investigators throughout the study.

Study endpoints

The primary study endpoint was to assess the efficacy of EHO‑85 in reducing the clinical signs and symptoms associated with Stage 1 PIs, compared to CT. Efficacy was assessed through three key measures: (1) Changes in erythema evaluated using the Transparent Disc Technique (TDT), whereby a transparent disc was applied with equal pressure over the affected area. Non-blanching indicated a persistent PI, while blanching was interpreted as resolution.^35,36 (2) Patient-reported QoL using a 100-mm Visual Analogue Scale (VAS QoL), where zero represented very low and 100 very high QoL.³⁷ Changes in discomfort levels were assessed under exploratory analysis, evaluated via a 7-point Likert scale at each visit (1: Totally unacceptable, 2: Unacceptable, 3: Slightly unacceptable, 4: Neutral, 5: Slightly acceptable, 6: Acceptable, 7: Perfectly Acceptable).

The secondary endpoint was to evaluate the effectiveness and overall safety of EHO-85 during the treatment period. Effectiveness measurements included the time to improvement in VAS QoL score and the time to discomfort reduction. Safety was evaluated based on the proportion of patients reporting AE and the number of withdrawals due to adverse reactions (AR).

Visit schedule and assessment timing

Subjects attended three scheduled visits. At Visit 1, day 0 (V1D0), eligibility was confirmed, demographic, baseline clinical data and medical history data were collected, and the initial assessments were performed, including VAS QoL, discomfort evaluation, TDT and a physical examination. Subjects were then allocated and began treatment. The second visit, V2 (D14±3), included follow-up assessments of QoL, discomfort, TDT, Braden Scale scoring and product compliance. If a Braden score indicated continued risk, product use was extended for another 30 days. At V3 (D45), final evaluations were conducted, including repeat assessments of QoL, discomfort, TDT, satisfaction rating using a 5-point Likert scale and product compliance evaluation. Any AE were also recorded at each visit (Supplementary Table 1).

Statistical analysis

The analysis was performed in the intention-to-treat (ITT) population, including all participants through to study completion. As no participants were lost to follow-up or excluded, the ITT and per-protocol populations were identical.

Continuous variables were summarised using means, standard deviations, medians and ranges, while categorical variables were expressed as counts and percentages. Percentages were calculated using N (number per treatment group or overall) as the denominator. Demographics and baseline disease characteristics were summarised by descriptive statistics. The efficacy of EHO-85 versus CT was evaluated using a parametric/nonparametric test, depending on the normality of data. All statistical analyses were two-sided, with significance set at a p-value<0.05.

Results

Subject disposition and baseline characteristics

A total of 50 subjects were enrolled and allocated equally: 25 received EHO-85 and 25 the CT (Supplementary Table 2). All participants completed the 45-day study and were included in the efficacy and safety analyses.

Mean age was 74.1±9.6 (SD) years old (EHO-85) and 73.8±11.5 (CT). Gender distribution was balanced (52% female in the EHO-85 group; 56% in the CT group). All participants were Caucasian. Most lived in urban areas (80% in EHO-85; 64% in the CT group). High school was the most common education level (44% in both groups). All patients had a relevant medical history, and most used concomitant medications (72% in EHO-85; 68% in the CT group). Full demographic details are provided in Table 1.

 

Table 1. Patients’ demographic data

 

Baseline (V1) physical examination findings were comparable across groups. Mean BMI was 29.9±6.7 (EHO-85) and 31.3±5.7 (CT). Vital signs (including temperature, heart rate, and respiratory rate) and systolic and diastolic blood pressure (BP) were similar between groups, and remained stable throughout V2 and V3.

Primary endpoints

Treatment efficacy in patients with Stage 1 PIs

At V1, all subjects had non-blanchable erythema, confirming the diagnosis of Stage 1 PIs (Figure 1). By V2, 28% (EHO‑85) and 56% (CT) exhibited blanchable skin. By V3, these proportions rose to 36% and 48%, respectively. Both groups improved significantly from baseline (EHO-85: p=0.016 at V2; p=0.004 at V3; CT: p<0.001 at both timepoints), but intergroup differences were not significant (p=0.085 at V2; p=0.567 at V3) (Figure 1).

 

Figure 1. Change in Transparent Disc Technique throughout visits 1, 2 and 3. *P=0.016 vs respective baseline V1; **P<0.001 vs respective baseline V1; $P=0.004 vs respective baseline V1; ##P < 0.001 vs respective baseline V1

 

Stratifying by Braden score (≤15 for continued treatment; >15 for discontinuation), group differences were not significant (p=0.153) (Supplementary Figure 1). Among those who discontinued treatment after V2 (n=12 [EHO-85] and n=16 [CT]), blanchable skin was observed in 58% of the patients receiving EHO-85 (p=0.016 versus baseline), with this percentage holding steady at V3. In the CT group, after V2, 75% showed blanchable skin (p<0.001 versus baseline), decreasing to 62% at V3 (p=0.002 versus baseline). Intergroup differences were not significant (V2: p=0.432; V3: p=1.000) (Supplementary Table 3).

For patients who continued to V3 (n=13 [EHO-85] and n=9 [CT]), blanchable skin rates were low: 15% (EHO-85) and 22% (CT) by V3. No significant intra- (p=0.500) or intergroup differences (V2: p=0.156; V3: p=1.000) were observed (Supplementary Table 3).

Quality of life

Both groups experienced significant QoL improvements. In the EHO-85 group, VAS QoL scores rose from 40.6 (V1) to 69.3 (V2) and 89.2 (V3) (p<0.001). In the CT group, QoL scores increased from 36.8 to 68.7 (V2) and 81.3 (V3) (p<0.001). Patients receiving EHO-85 treatment showed a significantly higher score at V3 (p=0.038) (Table 2).

 

Table 2. Summary of VAS QoL and discomfort levels (overall patients) at visits 1, 2 and 3

 

Among those who discontinued, QoL (EHO-85) rose from 35.6 to 80.6 at V2 and still improved to 91.2 at V3 (p=0.002); Similarly, QoL (CT) rose from 35.9 to 70.3 and 80.9 (p<0.001). EHO-85-treated patients showed a significantly higher score at V2 (p=0.045) (Supplementary Table 4).

Among those who continued, QoL improved significantly in both groups. EHO-85: 45.1 to 58.9 (V2; p=0.004) and 87.4 (V3; p=0.001); CT: 38.3 to 65.8 and 82.0 (p=0.008).

Discomfort levels

Discomfort levels decreased significantly in both groups (Table 2). In EHO-85 receivers, scores improved from 2.0 to 5.0 at V2 (p<0.001) and 6.3 at V3 (p<0.001). Similarly, scores in CT receivers rose from 2.2 to 4.8 at V2 (p<0.001) and 5.6 at V3 (p<0.001). No significant inter-group differences were observed (Table 2).

Among those who discontinued treatment, scores rose from 2.3 to 6.2 (V2) and 6.5 (V3) (p=0.002) among EHO-85 receivers, and from 2.4 to 5.2 (V2) and 5.7 (V3) (p<0.001) among CT receivers. At V2, the EHO-85 group had significantly better results (p=0.018) (Supplementary Table 5).

Among participants who continued treatment, both groups showed discomfort improvements. In the EHO-85 group, scores rose 1.8 to 3.9 at V2 and 6.1 at V3 (p=0.002). In the CT group, scores rose 2.0 to V2 (4.2) and V3 (5.4) (p<0.001 compared to V1).

Secondary endpoints

Time to QoL and discomfort improvement showed no significant differences between groups. The average time to QoL improvement was 16.5 days (EHO-85) and 14 days (CT) (p=0.153) (Figure 2A). The same durations were observed for discomfort reduction (p=0.153) (Figure 2B).

 

Figure 2. Time to VAS QoL score improvement in days (A), and time to discomfort level reduction in days (B). The discomfort level was evaluated by 7-point Likert scale at each visit (1=totally unacceptable, 2=unacceptable, 3=slightly unacceptable, 4=neutral, 5=slightly acceptable, 6=acceptable, 7=perfectly acceptable). VAS: visual analogue scale; QoL: quality of life

 

No AEs were reported in either treatment group (Table 3). No AE-related withdrawals were observed. AE rate was 0% for both groups across all study visits.   

 

Table 3. Proportion of patients who experienced adverse events and patients’ participation withdrawn due to adverse event occurrence

 

Treatment compliance was high. At V1 and V2, all participants showed ≥80% compliance with the treatment regimen. At V3, compliance data were available for the subset of patients that continued treatment (n=13 [EHO-85]; n=9 [CT]). At this timepoint, compliance remained high among both groups: 100% (13/13; EHO-85) versus 100% (9/9; CT). No product deficiencies were noted (Supplementary Table 6).

Finally, satisfaction was comparable between the two treatment groups (Supplementary Table 6): EHO-85 (mean 3.6; SD 0.5) versus CT (mean 3.4; SD 1.0).

Discussion

The present study assessed the use of EHO-85, indicated for PIs, lower limb ulcers, diabetic foot and anal fissures.¹³ Here, EHO-85 led to meaningful improvements in patient-reported and clinical outcomes. The primary endpoint of reducing non-blanchable erythema showed similar improvements in patients treated with EHO-85 and HOFA at D14 and D30. Among patients who discontinued treatment, a higher, but not statistically different, percentage of patients in the EHO-85 group maintained skin improvement through D45, whereas some patients receiving the CT treatment worsened. However, patients who continued treatment through D30 saw limited additional benefits in either group treatment.

Regarding QoL, by D45, the EHO-85 group achieved significantly higher QoL scores. Within this treatment group, patients who discontinued treatment showed a significant increase in QoL as early as D14. From D14 until D30, QoL continued to improve in both groups at a similar rate. This pattern not only suggests the presence of symptomatic benefits even after short-term EHO-85 treatment, but it also highlights a potential sustained or carryover symptomatic effect of both treatments after short-term use, likely tied to early symptom relief, such as reduced discomfort or enhanced skin condition. Interestingly, among those who continued treatment, QoL also improved in both treatment groups despite minimal changes in PIs status, possibly due to better skin hydration and reduced inflammation, or enhanced skin feel.

A direct and meaningful correlation was observed between patients’ well-being and symptom relief, with discomfort levels significantly improving in both treatment arms. Notably, EHO‑85 users who discontinued treatment early reported greater relief by D14 compared to those in the CT group, mirroring the improvements seen in QoL. Among patients who continued treatment, discomfort levels decreased even when visible wound healing was limited in both groups. Once again, this suggests that both treatments may confer additional benefits beyond visible PI repair, potentially contributing to symptom relief and enhanced well-being even in the absence of marked clinical improvement.

These findings, in the treatment of an early stage of PIs, are consistent with the holistic modulation of the PIs environment produced by EHO-85 as described previously.^22,24 Due to its biocompatible three-dimensional structure, EHO provides a barrier for mechanical protection of the skin.³⁹ EHO-85 also has a powerful moisturising and emollient action,²² such that a single application of EHO-85 significantly increases skin hydration and reduces transepidermal water loss (TEWL) within hours. In an open, intra-individual study involving eleven healthy subjects⁴⁰, EHO-85 was applied once to a 35 cm-sq area of the forearm and compared with an untreated control area on the same individual. The effects were evaluated over a 4-hour period following a single application. The results showed a rapid increase in skin hydration: +87% at 30 minutes, +108% at 2 hours and +98% (p<0.0001) at 4 hours. In addition, a significant decrease in TEWL was observed, with reductions of 20% at 2 hours (p=0.015) and 24% (p=0.002) at 4 hours.⁴¹ Skin hydration and TEWL are key indicators of epidermal barrier function. Its deterioration is linked to the onset of early-stage PIs, whereas its improvement is associated with the restoration of a mature epidermis.^42-44 Glycerine and Fucocert®, two key moisturising agents in EHO-85, contribute significantly to these effects. Glycerine plays a central role in hydration, elasticity, and skin repair,^{45, 46} while Fucocert®, a polysaccharide composed of L-fucose, D-galactose, and galacturonic acid, offers strong moisturising and self-emulsifying properties. It also helps form a protective film over the skin, supporting its defense against further breakdown.⁴⁷

Additionally, ischemia-reperfusion (I/R) injuries and subsequent oxidative stress caused by reactive oxygen species (ROS) also play an additional role in the development of Stage 1 PIs and increase the risk of progression to more severe and chronic stages.⁴⁸ The OELE component in EHO-85 is known for its high content of bioactive compounds, including flavonoids, oleuropeosides, and phenolic compounds, such as oleuropein and hydroxytyrosol, which altogether play a significant role against oxidative stress⁴² and, therefore, have a consistent role in preventing the progression of Stage 1 PIs.²²

The skin pH is also an important factor to consider. The pH of healthy skin is acidic on the surface,⁴⁹ so inducing a slightly acidic environment in the wound facilitated by EHO-85 can be beneficial in several ways: it helps improve oxygen release, angiogenesis, protease activity and reduces bacterial toxicity.^{50, 51} Overall, improved hydration,⁵⁰ oxidative stress⁵² and pH balance⁵³ reduce inflammation from the early stages, providing significant structural and functional recovery of the skin barrier, helping to close the vicious cycle underlying Stage 1 PI skin and leading to its improvement.⁵⁴ Histological data from Torrecillas-Baena et al²⁶ further support this mechanism by showing that EHO-85 reduced inflammatory infiltrates and promoted more mature tissue formation by D7, even in the absence of full wound closure. These anti-inflammatory effects likely contribute to the early symptomatic relief and improved skin condition that patients experienced, helping to explain why QoL and discomfort scores continued to improve even without visible recovery.

Regarding safety, both EHO-85 and HOFA were safe and well-tolerated, with no AE reported in this study. Product compliance was high, and no deficiencies or withdrawals due to safety concerns occurred. These findings are consistent with prior randomised controlled trials.^23,27-29

Finally, the mean satisfaction score for EHO-85 was 3.6, compared to 3.4 for the comparator (p=0.067). EHO-85 also showed lower variability in scores, indicating a more consistently positive user experience. This may be due to its favorable rheological properties, such as low viscosity under shear, good spreadability and ease of application, all commonly appreciated by users.²⁹ Besides, EHO-85 has been identified as cost-efficient, requiring smaller volumes per application, reinforcing EHO-85’s value as a practical and economical wound care option.²⁸

This study is not without limitations. The sample size was relatively small and limited to two countries, which may affect generalisability. The follow-up period was short, particularly for assessing long-term wound healing in patients requiring extended treatment. The open-label design could introduce observer or participant bias in subjective measures, such as discomfort and QoL.

Conclusion

EHO-85 demonstrated clinical efficacy comparable to a HOFA emulsion in resolving Stage PIs. Although both treatments showed similar improvements in PIs, EHO-85 provided significantly greater relief in discomfort and QoL by D14, particularly among patients who discontinued treatment early, suggesting that EHO-85 may have symptomatic benefits even after short-term use, likely due to its moisturising, antioxidant and anti-inflammatory properties, acting holistically. Therefore, the study highlights EHO-85 potential as a safe, user-friendly  and effective alternative for Stage 1 PI management with the aim of minimising the progression to more severe stages of the condition.

Implications for clinical practice

EHO-85 offers a safe, easy-to-apply option for rapidly improving QoL and discomfort levels in Stage 1 PIs. The product’s moisturising, antioxidant, and anti-inflammatory properties support skin barrier recovery while ensuring high compliance and satisfaction, which can be especially useful in older patients, emergency care and hospital settings.

Furthermore, considering the similarity in many pathophysiological aspects involved in DFU⁵⁵, EHO-85 could be used in the early stages of the condition, due to the combined action of its barrier effect, mechanical protection, powerful moisturising and emollient action and its powerful antioxidant properties, which counteract critical oxidative stress and inflammation caused by high blood glucose levels. The application of EHO-85 could constitute an approach for the treatment of early stages of DFU and comprehensive skin care for diabetic patients.

Further research

Further research with larger populations and extended follow-up is warranted to explore the long-term benefits and applicability of EHO-85 and determine whether early symptomatic improvements with EHO-85 translate into sustained clinical benefits and reduced progression to advanced PIs. Additionally, exploring its application in related conditions, such as DFU, would provide insight into its role in preventing and managing early-stage broader chronic wounds.

Acknowledgements

Medical writing support was provided by Meisys.

Conflict of interest

The authors declare no conflicts of interest.

Funding

This clinical trial was funded and sponsored by Noventure, S.L. (Barcelona, Spain).

Ethics approval

The Investigation was performed in Romania and Bulgaria, according to the revised Declaration of Helsinki for biomedical research involving human subjects, the rules of Good Clinical Practice (GCP) of the European Community, CPMP (CPMP/ICH/135/195; ICH Topic E6).

The EHO-85 study was approved by the Local Ethics Committee of SC Syncro Clinical Research SRL; Committee Opinion 77/15.01.2024, and by the Local Ethics Committee for Clinical Trials at MEDICAL CENTRE PROLET LTD.; Committee Opinion 000000026/19.04.2024. The trial was registered in the public database International Standard Randomised Controlled Trial Number (ISRCTN): ISRCTN13554350.

Informed consent statement

Informed consent was obtained from all subjects involved in the study.

Author contributions

All authors have read, reviewed and approved the final version of the manuscript for publication.

Author(s)

José Verdú-Soriano*¹, José Manuel Quesada-Gómez^2,3,4 MD, Stefan Dimitrov⁵ PhD, Miriam Berenguer-Pérez¹ PhD
¹Community Nursing, Preventive & Public Health Medicine & History of Sci Dept, WINTER-Heridas Research Group, University of Alicante, Spain
²Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Córdoba, Spain
³Department of Nursing, Pharmacology and Physiotherapy, University of Córdoba, Córdoba, Spain
⁴Consortium for Biomedical Research in Frailty & Healthy Ageing (CIBERFES), Institute of Health Carlos III, Madrid, Spain
⁵Prolet Medical Center EOOD, Rousse, Bulgaria

*Corresponding author email pepe.verdu@ua.es

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Supplementary information

Supplementary Table 1. Checklist of the items assessed at each visit.

 

Supplementary Table 2. Product administration

 

Supplementary Figure 1. Mean Braden scale score in patients receiving
either EHO-85 or the comparator treatment

 

Supplementary Table 3. Summary of transparent disc technique (TDT) readings throughout visits 1, 2, and 3 in the subgroups of patients, by Brande scale scores.

 

Supplementary Table 4. VAS QoL in subjects who did or did not continue
treatment for an additional month

 

Supplementary Table 5. Discomfort assessment in subjects who did or did not
continue treatment for an additional 1 month.

 

Supplementary Table 6. Product compliance, deficiency, and satisfaction.