An interventional study of PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional) and PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional) in Venous Leg Ulcer, sponsored by Lohmann & Rauscher. Recruiting at 9 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Lohmann & Rauscher · Not applicable, Interventional, and Treatment
Among 15 studies in Varicose Ulcer with a site in Poland — 3 open to participants now, 4 under way, 2 of them phase 3. Varicose Ulcer · Poland.
Among the 15 studies in Varicose Ulcer with a site in Poland, this one is the 7th largest by planned enrollment of the 13 interventional ones, is one of 3 that started in 2025, is one of 6 with no phase, and was the 13th registered.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →3 of the 15 studies in Varicose Ulcer with a site in Poland are open now, in 10 countries. Each count lists the studies.
Of the 52 Varicose Ulcer studies recruiting now, 42 (81%) set no upper age limit and 5 (10%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2025.
Median enrollment 150 across the 13 interventional studies, 160 across the 2 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
15 of 15 have an industry lead sponsor. The 10 most frequent:
Lohmann & Rauscher is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Lohmann & Rauscher has 3 studies filed under Varicose Ulcer — fewer than ten, so there is no comparison to draw.
3 of the studies in Varicose Ulcer with a site in Poland that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568627Phase 3MediWound LtdA Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) | 2026-12 |
| NCT06489028Phase 3RHEACELL GmbH & Co. KGAllogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) | 2027-04 |
| NCT05805137CutoSense OyMonitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System | 2026-11-30 |
Among the 15 studies in Varicose Ulcer with a site in Poland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
During the screening, all patients will be assessed for inclusion and exclusion criteria and wound exudation status. Eligible patients with slight or moderate wound exudation will be randomly assigned to treatment with either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. The patients who fulfil all other eligibility criteria but have high level of wound exudation will enter a 7-days run-in period, during which they will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored compression therapy with Rosidal® 1C. During the run-in period they should receive appropriate treatment including systemic antimicrobial drug therapy if required. After this time, these patients should be re-assessed and in case they still fulfil all eligibility criteria, and the exudation decreased at least to a moderate level, they will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. In case the exudation would not decrease within this period or other eligibility criteria are not met anymore, they will be screened out.
Upon randomisation, all patients will receive the assigned dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also continue to receive adequate compression and, if necessary, systemic antimicrobial drug therapy. During the study participation, selected parameters of the wound will be assessed at Baseline, Interim Visit, and EOT visit. In addition, dressing changes may be performed in-between on as needed basis. After 3 weeks of treatment with Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB, all patients will complete the study. Their further treatment (if necessary), will not be the part of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient has signed
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the assigned wound dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also receive adequate compression and, if necessary, systemic antimicrobial drug therapy.
Device: PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
Patients will receive the assigned wound dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also receive adequate compression and, if necessary, systemic antimicrobial drug therapy.
Device: PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro)
on a 4-grade scale there 0 means no maceration and 4 means severe maceration
Time frame: 3 weeks
Wound area change over time
in mm2
Time frame: 3 weeks
Change of necrotic & fibrinous & granulation tissue rate in the wound bed
in %
Time frame: 3 weeks
Change of wound infection status
by a TILI (Therapeutical Index for Local Infections) score with a range 1-6. TILI \< 5 indicates a wound without infection, whereas TILI ≥ 5 means a local wound infection.
Time frame: 3 weeks
Product safety (rate of product-related complications)
by rate of product-related complications
Time frame: 3 weeks
Change of wound exudation and presence of peri-wound oedema
by the investigators' assessment of exudation grade
Time frame: 3 weeks
Change in patient's pain
By NRS (numeric rating scale), with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 3 weeks
Product usability
by user and patient questionnaire
Time frame: 3 weeks
Change in patient's quality of life
by Wound QoL-17 (wound quality of life) questionnaire
Time frame: 3 weeks
Oedema chamge
by measurement of limb circumference
Time frame: 3 weeks
Sub-bandage pressure levels retention
difference of the pressure levels, measured at the time of application and before the next dressing change with a wireless sensor
Time frame: 3 weeks
Not enrolling at this site.
Not enrolling at this site.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Oct 2026, 12 months after the start.
Of 66 industry-sponsored interventional studies with no phase under Varicose Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's planned 12 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Lohmann & Rauscher