Comparative study in adults with pressure ulcer stage I

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13554350

Enrollment

Registered

2025-09-24

Start date

2024-04-12

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure ulcer stage I Skin and Connective Tissue Diseases

Interventions

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 e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (>18 years) with pressure ulcer stage 1 (non-blanching erythema [category I PU])

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Bulgaria, Romania

Contacts

Public ContactAlina Iordache

alina.iordache@cebis-int.com+40 (0)21 320 32 81

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026