Cellulose membrane dressing for hard-to-heal venous leg ulcers
| ISRCTN | ISRCTN80037348 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80037348 |
| Sponsors | Jan Długosz University in Czestochowa, Specialist Hospital No. 2 in Bytom, John Paul II District Hospital in Włoszczowa |
| Funder | Investigator initiated and funded |
- Submission date
- 19/12/2025
- 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 long-lasting wounds that happen when blood doesn’t flow properly through the veins in the legs. They can be painful and slow to heal. This study is looking at whether a new type of dressing made from bacterial cellulose (called Bioprocess®) works as well or better than a commonly used silver-based dressing (Suprasorb A + Ag). Both dressings are designed to protect the wound and help it heal.
Who can participate?
Adults who have a venous leg ulcer confirmed by a Doppler ultrasound scan. Participants must be suitable for outpatient care and compression therapy.
What does the study involve?
People who join the study will be randomly placed into one of two groups. One group will have their ulcer treated with the bacterial cellulose dressing, and the other group will have the silver-based dressing. In both groups, the wound will be cleaned with saline, covered with gauze, and treated with compression bandages. Participants will visit the clinic once a week until their ulcer heals. The size of the ulcer will be measured every week.
What are the possible benefits and risks of participating?
Taking part may help your ulcer heal and give you access to regular care. However, there is no guarantee that your ulcer will heal faster. Both dressings are commonly used and considered safe, but as with any treatment, there is a small risk of irritation or allergic reaction.
Where is the study run from?
The study is being carried out in two outpatient surgical centres in Poland.
When is the study starting and how long is it expected to run for?
The study started in February 2022 and is expected to finish in September 2024.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
ikingaxd@gmail.com
e.rojczyk@ujd.edu.pl
Contact information
Public, Scientific
Jan Dlugosz University in Czestochowa
Czestochowa
42-200
Poland
 ORCID ID |
0000-0003-4897-8000 |
|---|---|
| Phone | +48 501193857 |
| ikingaxd@gmail.com |
Public, Scientific, Principal investigator
Jan Dlugosz University in Czestochowa
Czestochowa
42-200
Poland
| ORCID ID |
0000-0002-2977-5542 |
|---|---|
| Phone | +48 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 | Topical application of a bacterial cellulose membrane (Bioprocess®) versus a silver-containing calcium alginate dressing (Suprasorb A + Ag) for chronic venous leg ulcers: a randomised controlled study | |
| Study acronym | BC-VLU | |
| Study objectives | Primary objective: To compare the effectiveness of a bacterial cellulose membrane dressing (Bioprocess®) versus a silver-containing calcium alginate dressing (Suprasorb A + Ag), both used with standard compression therapy, in adults with chronic venous leg ulcers. Secondary objectives: To compare the rate of ulcer area reduction over time and the proportion of ulcers completely healed during follow-up. | |
| Ethics approval(s) |
Approved 15/10/2013, Regional Scientific Research Commission in Katowice, SUM, KB124/2013 (Regional Scientific Research Commission in Katowice (SUM), Katowice, 40-055, Poland; +48 32 208 3600; nauka@sum.edu.pl), ref: KB124/2013 | |
| Health condition(s) or problem(s) studied | Chronic venous leg ulcers (VLU) | |
| Intervention | Arm 1 (Intervention): Bacterial cellulose membrane dressing (Bioprocess®; Biofil, Curitiba, Brazil) applied to the ulcer after saline irrigation, extending ~1 cm beyond wound margins, covered with sterile gauze; compression bandaging applied (target pressure 25–35 mmHg). Weekly physician review; ulcer area measured every 7 days by planimetry. Arm 2 (Control): Silver-containing calcium alginate dressing (Suprasorb A + Ag; Lohmann & Rauscher) applied after saline irrigation, covered with sterile gauze; compression bandaging as above (25–35 mmHg). Dressing replaced daily until healing; weekly physician review; ulcer area measured every 7 days by planimetry. Co-interventions (both arms): Standard wound cleansing (saline), debridement as clinically indicated, and standard pharmacotherapy for chronic venous disease (micronized flavonoid fraction: diosmin 450 mg + hesperidin 50 mg daily). | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Bioprocess® (bacterial cellulose membrane dressing) vs Suprasorb® A + Ag (silver-containing calcium alginate dressing). | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 01/09/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Adults (≥18 years) 2. Presence of a chronic venous leg ulcer (VLU) on the lower limb, confirmed by Doppler ultrasonography 3. Ankle–brachial index (ABI) within the acceptable/normal range 4. Eligible for standard compression therapy and outpatient follow-up 5. Prior standard care (e.g., compression and conventional dressings) without complete healing before enrolment 6. Written informed consent |
| Key exclusion criteria | 1. Non-venous ulcers (e.g., arterial, diabetic foot, vasculitic, malignant ulcers) 2. Clinically significant arterial disease / ABI < 0.7 or > 1.3 3. Active severe wound infection requiring systemic antibiotics at baseline 4. Known allergy to dressing components (bacterial cellulose, alginate, silver) 5. Pregnancy or breastfeeding 6. Inability to provide informed consent or comply with compression therapy/follow-up |
| Date of first enrolment | 01/02/2022 |
| Date of final enrolment | 01/09/2024 |
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 Bioethics Committee (Komisja Bioetyczna Śląskiej Akademii Medycznej w Katowicach).
