Octenidine gel plus a hydrogel dressing compared with a silver alginate dressing for venous leg ulcers: a randomized clinical trial
| ISRCTN | ISRCTN13181127 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13181127 |
| Sponsor | Jan Długosz University |
| Funder | Jan Długosz University |
- Submission date
- 26/12/2025
- Registration date
- 30/12/2025
- Last edited
- 29/12/2025
- 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
Venous leg ulcers are chronic wounds caused by problems with blood flow in the leg veins. They can be slow to heal and often recur. Many different dressings are used in practice, so it is important to know which approaches lead to better healing. This study aims to compare, over 4 weeks, two dressing regimens for venous leg ulcers: (1) octenidine gel plus a hydrogel dressing versus, and (2) a silver-containing calcium alginate dressing.
Who can participate?
Patients aged 18–80 years with a venous leg ulcer that has not healed for more than 3 months and has an area of 20–60 cm²
What does the study involve?
At the start (baseline) and again after 4 weeks, each participant’s ulcer is assessed using the RESVECH 2.0 scale. RESVECH 2.0 is a standardised wound assessment that scores: wound dimensions (as categories within the scale), depth/affected tissues, wound edges, tissue type in the wound bed, exudate, and signs of infection/inflammation (including features consistent with biofilm). The total score is the sum of these elements; a lower score indicates a better/healed wound.
At dressing changes in both groups, the wound is cleansed using an antiseptic solution containing 0.1% polyhexanide and poloxamer 188, followed by mechanical debridement if needed (e.g., using a sterile Volkmann spoon). Participants then receive either:
1. Experimental group: octenidine gel applied to the ulcer bed and covered with a hydrogel dressing, or
2. Control group: a silver-containing calcium alginate dressing.
Dressings are replaced every 3 days for 4 weeks.
What are the possible benefits and risks of participating?
Possible benefits include regular wound assessment and treatment that may improve wound healing. Possible risks include local skin irritation, discomfort during dressing changes or debridement, allergic reactions to dressing components (octenidine or silver), and general risks associated with chronic wounds (e.g., infection or delayed healing). Participants are monitored and appropriate medical care is provided if needed.
Where is the study run from?
The study is run from Jan Długosz University in Częstochowa (Poland), with participant treatment/data collection carried out at:
1. The Surgical Outpatient Clinic of the Healthcare Centre of Jan Paweł II District Hospital in Włoszczowa
2. The Wound Treatment Clinic of the Specialist Hospital of Priest B. Markiewicz, Subcarpathian Oncology Centre in Brzozów.
When is the study starting and how long is it expected to run for?
June 2024 to June 2025
Who is funding the study?
Jan Długosz University in Częstochowa (Poland)
Who is the main contact?
1. Kinga Spyrka, ikingaxd@gmail.com
2. Dr Marek Kucharzewski, m.kucharzewski@ujd.edu.pl
Contact information
Public, Scientific
Jerzego Waszyngtona 4/8
Częstochowa
42-200
Poland
 ORCID ID |
0000-0003-4897-8000 |
|---|---|
| Phone | +48 (0)501193857 |
| ikingaxd@gmail.com |
Public, Scientific, Principal investigator
Jerzego Waszyngtona 4/8
Częstochowa
42-200
Poland
| ORCID ID |
0000-0001-7950-679X |
|---|---|
| Phone | +48 (0)660469080 |
| m.kucharzewski@ujd.edu.pl |
Public, Scientific
Jerzego Waszyngtona 4/8
Częstochowa
42-200
Poland
| ORCID ID |
0000-0002-2977-5542 |
|---|---|
| Phone | +48 (0)605466076 |
| e.rojczyk@ujd.edu.pl |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Clinical effectiveness of octenidine gel with hydrogel dressing compared with silver-containing calcium alginate dressing in venous leg ulcers: randomized trial | |
| Study acronym | OCTAS-VLU | |
| Study objectives | To compare the clinical effectiveness of two dressing regimens for venous leg ulcers (VLUs) — octenidine-based gel plus a hydrogel dressing versus a silver-containing calcium alginate dressing — over a 4-week treatment period, using the RESVECH 2.0 scale (total score). | |
| Ethics approval(s) |
Approved 29/09/2015, Ethics Committee of the Medical University of Silesia in Katowice (Poniatowskiego 15, Katowice, 40-055, Poland; +48 (0)32 208 35 46; kombioet@sum.edu.pl), ref: KNW/0022/KB1/100/I/15 | |
| Health condition(s) or problem(s) studied | Chronic venous leg ulcers (VLUs) | |
| Intervention | Randomisation was implemented using sequentially numbered, sealed opaque envelopes containing the group allocation. Envelopes were opened only after a participant had been enrolled/consented. Experimental intervention (Arm A): Octenidine gel + hydrogel dressing At each dressing change, the wound was cleansed with an antiseptic solution containing 0.1% polyhexanide and poloxamer 188, followed by mechanical debridement with a sterile Volkmann spoon as required. Octenidine gel was then applied to the ulcer bed and covered with a hydrogel dressing. Dressings were replaced every 3 days for 4 weeks. Control intervention (Arm B): Silver-containing calcium alginate dressing The same wound cleansing and debridement procedure was used (0.1% polyhexanide + poloxamer 188; Volkmann spoon debridement as required). A silver-containing calcium alginate dressing was applied. Dressings were replaced every 3 days for 4 weeks. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Octenidine gel (octenidine dihydrochloride) + hydrogel dressing , silver-containing calcium alginate dressing | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Diagnosis of venous leg ulcer (VLU); non-venous origin excluded by Doppler ultrasonography 2. Chronic wound treated unsuccessfully for >3 months 3. Wound area 20–60 cm² 4. Written informed consent |
| Key exclusion criteria | 1. Allergy to octenidine or silver 2. No written informed consent |
| Date of first enrolment | 01/06/2024 |
| Date of final enrolment | 01/06/2025 |
Locations
Countries of recruitment
- Poland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
29/12/2025: Study's existence confirmed by the Ethics Committee of the Medical University of Silesia in Katowice.
