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The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| URGO 310 3082 | Experimental |
| |
| Aquacel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dressing | Device | the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor). |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment. | The main evaluation criterion is the relative planimetric regression of the wound surface area, calculated according to the following formula, from centralised planimetric measurements: Regression of the area (%) = [(ST0-STlast)/ST0] x 100 ST0: Surface area of the lesion measured on the day of inclusion STlast: Surface area of the lesion at the last planimetric evaluation available | Week 1, 2, 4 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between the two devices of percentage of lesions in which the evolution is positive (defined by a relative regression at least 40% of wound surface) after monitoring for 6 weeks. | Week 1, 2, 4 and 6 | |
| Comparison between the two groups of percentage of debrided lesions (defined by a lesion with more than 70% of its surface covered by granulation tissue of a "red colour" on the colorimetric scale), at the last available evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Rothschild | Paris | 75012 | France |
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| Dressing | Device | the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation. The dressing can remain in place for up to 7 days. |
|
| Week 1, 2, 4 and 6 |
| Comparison between the two strategies of percentage of patients in whom at least one problem of pain was detected during care (VAS score at the end of care > 30 mm) | Week 1, 2, 4 and 6 |
| Comparison between the 2 groups of the percentage of wound care associated with manual debridement | Week 1, 2, 4 and 6 |
| Comparison between the two groups of the evolution of the patients' quality of life between inclusion and the last available visit. This quality of life will be assessed using the EuroQol-5Dâ„¢ questionnaire | Week 1, 2, 4 and 6 |
| Comparison between the 2 groups of the percentage of the participants number with Adverse Events | Week 1, 2, 4 and 6 |
| Comparison between the 2 groups of the mean number of dressing changes per week. | Week 1, 2, 4 and 6 |
| Comparison between the 2 groups of the easiness application and removal | Week 1, 2, 4 and 6 |
| Comparison between the 2 groups of the percentage of good or very good conformability | Week 1, 2, 4 and 6 |
| Comparison between the 2 groups of the mean value for overall performance score | This score will be between 0 and 36 | Week 1, 2, 4 and 6 |
| 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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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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