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The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing. Saline is widely used for venous leg ulcer cleansing and has served as comparator or standard treatment in clinical trials evaluating new cleansing products to prove that it is as good as the standard treatment. Data will also be collected on the patients' quality of life and any adverse events that may arise during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM242-Solution | Experimental |
| |
| Saline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM242-Solution | Device | HM242-Solution compared to Saline compared in patients with a venous leg ulcer |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of the study is to demonstrate that the HM242-Solution performs at least comparably to Saline regarding wound healing. | The primary variable is defined as the relative reduction of the wound area of a patient in percentage 28 days (4 weeks) after baseline. The wound size area is measured on site by the Tracing method. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joerg Brechbuehl | Contact | +41 58 258 50 00 | joerg.brechbuehl@bbraun.com | |
| Thomas Frei | Contact | +41 58 258 50 00 | thomas.frei@bbraun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asl Napoli 3 Sud | Recruiting | Gragnano | Napoli | 80054 | Italy |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Saline | Device | HM242-Solution compared to Saline compared in patients with a venous leg ulcer |
|
| Dept. of Clinical and Experimental Medicine University of Pisa | Recruiting | Pisa | Toscany | 56126 | Italy |
|
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |