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| Name | Class |
|---|---|
| Clean Data Labs | UNKNOWN |
| Sphera Clinical Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound area change over time | in mm2 | 3 weeks |
| Change of necrotic & fibrinous & granulation tissue rate in the wound bed | in % | 3 weeks |
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Inclusion Criteria:
Age ≥ 18 years
Infected* venous** leg ulcer
Slightly to moderately exuding wound***
Patient has signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daria Trofimenko, MD | Contact | 02631996385 | daria.trofimenko@de.lrmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Konrad Pańczak, MD | LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń | Recruiting | Bialystok | 15-879 | Poland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2025 | Sep 11, 2025 |
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Patients will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB in a 1:1 ratio.
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Primary endpoint ans some secondary endpoints will be re-confirmed by a blinded assessment of the wound photographs
|
| 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. |
|
| 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. | 3 weeks |
| Product safety (rate of product-related complications) | by rate of product-related complications | 3 weeks |
| Change of wound exudation and presence of peri-wound oedema | by the investigators' assessment of exudation grade | 3 weeks |
| Change in patient's pain | By NRS (numeric rating scale), with zero meaning "no pain" and 10 meaning "the worst pain imaginable" | 3 weeks |
| Product usability | by user and patient questionnaire | 3 weeks |
| Change in patient's quality of life | by Wound QoL-17 (wound quality of life) questionnaire | 3 weeks |
| Oedema chamge | by measurement of limb circumference | 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 | 3 weeks |
| Centrum Medyczne Ultramed | Withdrawn | Krakow | Poland |
| MelissaMed Poradnia Chirurgiczna | Withdrawn | Lodz | Poland |
| Mikomed Spółka Z Ograniczoną Odpowiedzialnością | Recruiting | Lodz | Poland |
|
| Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne | Recruiting | Lodz | Poland |
|
| PP CLINIC Pietrzyk spółka partnerska lekarzy | Recruiting | Lublin | Poland |
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| SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota | Recruiting | Ostróda | Poland |
|
| Lecran - Centrum Opieki Nad Ranami-Kunickiego | Recruiting | Wroclaw | Poland |
|
| Specjalistyczna Pomoc Medyczna "Medservice" | Recruiting | Zabrze | Poland |
|
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2025 | Sep 11, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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