Comparative study in adults with pressure ulcer stage I
| ISRCTN | ISRCTN13554350 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13554350 |
| Secondary identifying numbers | Protocol Number: CBSNOV03052023 |
- Submission date
- 20/08/2025
- Registration date
- 24/09/2025
- Last edited
- 24/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
A pressure ulcer is a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction. These wounds occur frequently among individuals who have difficulty moving, or cannot reposition themselves, such as the frail elderly, individuals undergoing surgery, or individuals with spinal cord injury. However, anyone of any age could develop a pressure ulcer if they are exposed to prolonged, unrelieved pressure and shear forces. Comprehensive assessment of the individual and his or her pressure ulcer informs the development of the most appropriate management plan and ongoing monitoring of wound healing. Currently in clinical practice pressure ulcers are monitored using the clinical judgment of a health professional supported by pressure ulcer assessment tools. A pressure ulcer classification system is used to aid in the description of the extent of skin and tissue damage presenting as a pressure ulcer. Treatment for pressure ulcers varies depending on the grade of the ulcer. The aim of this study is to evaluate the safety and effectiveness of EHO-85 (SKINDOX®) vs hyperoxygenated fatty acid in patients with stage I pressure ulcers.
Who can participate?
Patients aged over 18 years with stage I pressure ulcers
What does the study involve?
Participants will be randomly allocated to treatment with SKINDOX® (EHO-85) or hyperoxygenated fatty acids. The aim is to evaluate the safety and effectiveness of the two treatments. Participants will receive the assigned treatment according to standard care practices. The study includes three visits for a duration of 45 days to assess the condition of the skin, discomfort level, quality of life and any adverse events.
What are the possible benefits and risks of participating?
This product may be beneficial for the regeneration of tissues and the improvement of metabolic processes. The participants did not receive any specific and/or direct benefits from participating in this study. There are no known risks in using this product. However, it is recommended not to use the product in the case of individual hypersensitivity or allergy to one or more components.
Where is the study run from?
Noventure S.L. (Spain)
When is the study starting and how long is it expected to run for?
January 2024 to October 2024
Who is funding the study?
Noventure S.L. (Spain)
Who is the main contact?
Félix Berrocal Orvay, fberrocal@noventure.com
Contact information
Public, Scientific, Principal investigator
47 Theodor Pallady
Bucharest
032275
Romania
| Phone | +40 (0)21 320 32 81 |
|---|---|
| alina.iordache@cebis-int.com |
Study information
| Study design | Open-label multicenter comparative clinical study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Comparative |
| Study setting(s) | GP practice |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Open-label, multicenter clinical study to evaluate the safety and efficacy of EHO-85 (SKINDOX®) vs hyper-oxygenated fatty acid in adult patients diagnosed with pressure ulcer stage I |
| Study objectives | Primary objectives: To assess the efficacy of EHO 85 (SKINDOX®) versus hyperoxygenated fatty acid in reducing the clinical symptomatology associated with pressure ulcer stage 1. Secondary objectives: To assess the safety and effectiveness of EHO 85 (SKINDOX®) versus hyperoxygenated fatty acid by collecting the safety events that occur during product administration until study closure. |
| Ethics approval(s) |
1. Approved 15/01/2024, Local Ethics Committee for Clinical Trials of S.C. Syncro Clinical Research S.R.L. (Str. Stadionului no. 16, Brașov, 500064, Romania; +40 (0)368 006 915; contact@syncromedic.ro), ref: 77/15.01.2024 2. Approved 19/04/2024, Local Ethics Committee for Clinical Trials at Medical Centre Prolet LTD (25 Olimpi Panov Str., Rousse, 7000, Bulgaria; +359 (0)887 842 514; med.center.prolet@gmail.com), ref: 000000026/19.04.2024 |
| Health condition(s) or problem(s) studied | Pressure ulcer stage I |
| Intervention | Each patient signed the informed consent form for participating in the study. After the consent signature, the data collection started. The doctors collected prospective data related to the clinical efficacy and safety. The following assessment tools were used during the study: 1. VAS QoL (0-100 mm Visual Analogue Scale score) 2. Discomfort evaluation 3. Transparent Disc Technik assessment 4. Braden Scale score 5. Satisfaction in using the product Patients who are eligible for the study treatment will receive EHO 85 (SKINDOX®) or hyperoxygenated fatty acid. The products will be allocated 1:1. Each product will be administered for a period of 2 weeks. EHO-85 (SKINDOX®): The product was applied two to three times daily on risk or susceptible areas, spreading it gently with the fingertips and massaging to facilitate absorption. Hands were washed after each application. The product was administered for a period of 2 weeks. In case Braden scale was present equal or higher risk in developing pressure ulcers, than it was decided to continue on product administration for 1 month. Hyperoxygenated fatty acid (Corpitol Emulsion): The necessary amount of Corpitol Emulsion was applied on the red, dry area at risk of ulceration. This was repeated two to three times a day. The product was gently spread and massaged to help the penetration of the Corpitolinol 60 microparticles. The product was administered for a period of 2 weeks. In case Braden scale was present equal or higher risk in developing pressure ulcers, then it was decided to continue on product administration for 1 month. Visit 2 (Day 14) took place after 2 weeks of product administration. During this visit (V2), the investigator evaluated the risk of developing PU using the Braden Scale. In case any risk was determined, the investigator has the possibility to advise product administration for an additional month. Additionally, at Visit 3 (Day 45), the investigator evaluated the satisfaction in product utility through a 5-point Likert scale: 1- Very Unsatisfied; 2- Unsatisfied; 3- Neutral; 4-Satisfied; 5- Very Satisfied. |
| Intervention type | Other |
| Primary outcome measure | 1. Transparent Disc Technik (TDT) measured at Visit 1 (Day 0), Visit 2 (Day 14) and Visit 3 (Day 45) 2. Quality of life measured using a Visual Analogue Scale (from 0 mm - very low to 100 mm - very high) at Visit 1 (Day 0), Visit 2 (Day 14) and Visit 3 (Day 45) |
| Secondary outcome measures | 1. Time to quality of life improvement measured using the VAS QoL (from 0 mm - very low to 100 mm - very high), recorded at each visit (Visit 1 [Day 0], Visit 2 [Day 14] and Visit 3 [Day 45]), and calculated as the time from baseline (Visit 1 [Day 0]) to the first observed improvement 2. Time to discomfort level reduction measured using a 7-point Likert scale (1 = Totally unacceptable to 7 = Perfectly acceptable), assessed at Visit 1 (Day 0), Visit 2 (Day 14) and Visit 3 (Day 45). Time to reduction is calculated as the interval from baseline to the first recorded improvement in score 3. Proportion of patients experiencing adverse events (AEs) recorded throughout the entire study period (Visit 1 to Visit 3) using AE forms |
| Overall study start date | 15/01/2024 |
| Completion date | 07/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | Adult patients (>18 years) with pressure ulcer stage 1 (non-blanching erythema [category I PU]) |
| Key exclusion criteria | 1. Hypersensitivity or individual allergy to one or more components of the product 2. Known drug and/or alcohol abuse 3. Known medical history of peripheral artery disease 4. Other – different – clinical conditions of skin layers 5. Chronic pathological skin conditions |
| Date of first enrolment | 12/04/2024 |
| Date of final enrolment | 23/08/2024 |
Locations
Countries of recruitment
- Bulgaria
- Romania
Study participating centres
Brașov
500064
Romania
Bucharest
031804
Romania
Ruse
7000
Bulgaria
Sponsor information
Industry
Avd. Diagonal 601, 8 Floor
Barcelona
08028
Spain
| Phone | +34 (0)606450251 |
|---|---|
| fberrocal@noventure.com | |
| Website | https://noventure.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Individual Participant Data (IPD) will be shared but only in anonymized form to protect participant privacy. The datasets generated during and/or analysed during the current study will be available upon request from the main contact person, based on the purpose of processing. |
Editorial Notes
20/08/2025: Study's existence confirmed by the Local Ethics Committee for Clinical Trials of S.C. Syncro Clinical Research S.R.L.
