Venous Leg UlcerNCT07211243
Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers
A study testing 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 people with Venous Leg Ulcer, run by Lohmann & Rauscher at 9 sites in Poland.
Trial summary
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- 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)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesPoland
- Study dates
- 23 Sep 2025to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Infected* venous** leg ulcer
- Slightly to moderately exuding wound***
- Patient has signed informed consent
- as per CDC definition, also TILI score ≥ 5 ABPI > 0.8 and < 1.2 * patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases
Who cannot join
- Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study
- Wounds with exposed cartilage tissue (hyaline cartilage)
- Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)
- Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)
- Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Poland9 sites, 7 recruiting
- Recruiting
ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń
Bialystok, 15-879
Nonna Nowak, MD, PhD
- Withdrawn
Centrum Medyczne Ultramed
Krakow
- Withdrawn
MelissaMed Poradnia Chirurgiczna
Lodz
- Recruiting
Mikomed Spółka Z Ograniczoną Odpowiedzialnością
Lodz
Jacek Mikosiński, MD
- Recruiting
Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne
Lodz
Przemysław Lipiński, MD
- Recruiting
PP CLINIC Pietrzyk spółka partnerska lekarzy
Lublin
Łukasz Pietrzyk, MD
- Recruiting
SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota
Ostróda
Katarzyna Rybołowicz, MD
- Recruiting
Lecran - Centrum Opieki Nad Ranami-Kunickiego
Wroclaw
Konrad Pańczak, MD
- Recruiting
Specjalistyczna Pomoc Medyczna "Medservice"
Zabrze
Wojciech Saucha, MD
About this study
Official title: Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
Read the detailed description
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.
- Conditions
- Venous Leg Ulcer
- Being tested
- PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional), PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
- Keywords
- maceration, bacterial cellulose dressing, PHMB, antimicrobial dressing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)Device
Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)Device
Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
| Study group | Role | What they receive |
|---|---|---|
| Suprasorb®X+PHMB Pro | Experimental | 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. Receives: Device: PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional) |
| Suprasorb®X+PHMB | Active comparator | 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. Receives: Device: PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Secondary outcomes (10)
Wound area change over time
in mm2
Measured: 3 weeks
Change of necrotic & fibrinous & granulation tissue rate in the wound bed
in %
Measured: 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.
Measured: 3 weeks
Product safety (rate of product-related complications)
by rate of product-related complications
Measured: 3 weeks
Change of wound exudation and presence of peri-wound oedema
by the investigators' assessment of exudation grade
Measured: 3 weeks
Change in patient's pain
By NRS (numeric rating scale), with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 3 weeks
Product usability
by user and patient questionnaire
Measured: 3 weeks
Change in patient's quality of life
by Wound QoL-17 (wound quality of life) questionnaire
Measured: 3 weeks
Oedema chamge
by measurement of limb circumference
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start23 Sep 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lohmann & Rauscher
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clean Data Labs, Sphera Clinical Research
- Responsible party
- Sponsor
- Investigators
- Konrad Pańczak, MD, Principal investigator, LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211243
- Sponsor's protocol ID
- 2024-07
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT07211243
- Acronym / sponsor ID
- 2024-07
- Conditions
- Venous Leg Ulcer
- Keywords
- maceration, bacterial cellulose dressing, PHMB, antimicrobial dressing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lohmann & RauscherIndustry (pharma, biotech, devices)
- Collaborators
- Clean Data Labs, Sphera Clinical Research
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Suprasorb®X+PHMB Pro | Experimental | 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. |
| Suprasorb®X+PHMB | Active comparator | Device: PHMB-impregnated biocellulose wound dressing without 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Infected* venous** leg ulcer
- Slightly to moderately exuding wound***
- Patient has signed informed consent
Key exclusion criteria (5 listed)
- Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study
- Wounds with exposed cartilage tissue (hyaline cartilage)
- Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)
- Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)
- Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHMB-impregnated biocellulose wound dressing with 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. | Device | Suprasorb®X+PHMB Pro |
| PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy. | Device | Suprasorb®X+PHMB |
Primary outcome
Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro)
Time frame: 3 weeks
on a 4-grade scale there 0 means no maceration and 4 means severe maceration
10 secondary outcomes
Wound area change over time
Time frame: 3 weeks
Change of necrotic & fibrinous & granulation tissue rate in the wound bed
Time frame: 3 weeks
Change of wound infection status
Time frame: 3 weeks
Product safety (rate of product-related complications)
Time frame: 3 weeks
Change of wound exudation and presence of peri-wound oedema
Time frame: 3 weeks
Change in patient's pain
Time frame: 3 weeks
Product usability
Time frame: 3 weeks
Change in patient's quality of life
Time frame: 3 weeks
Oedema chamge
Time frame: 3 weeks
Sub-bandage pressure levels retention
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konrad Pańczak, MD principal investigator
LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Venous Leg Ulcer, run by Lohmann & Rauscher at 9 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daria Trofimenko, MD (02631996385, daria.trofimenko@de.lrmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.