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The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotulle | Experimental |
| |
| Urgotul | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotulle | Device | Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain at dressing removal | pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion | 4weeks | |
| Number of patients with adverse events as a measure of safety and tolerability | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Patient who have been taking corticoids > 10mg / day or cytostatics by systematic way for the three months prior to inclusion
Patient who have undergone surgery of saphenous trunk in the two months prior to inclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg ^Hospital | Bispebjerg | NV | 2400 | Denmark | ||
| Arhus Sygehus |
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| URGOTUL | Device | Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix |
|
| Aarhus |
| 8000 |
| Denmark |
| Odense Universitets Hospital | Odense | 5000 | Denmark |
| Cabilet Medical | Abbeville | 80100 | France |
| CHU Sud | Amiens | 80054 | France |
| Cabinet Medical | Angoulême | 16000 | France |
| Centre Hospitalier | Arras | 62022 | France |
| Cabinet Médical | Bagnoles-de-l'Orne | 61140 | France |
| CHU | Brest | 29609 | France |
| CHU | Caen | 14033 | France |
| Hôpital Manchester | Charlevilles Mézières | 80011 | France |
| Centre Hospitalier de Douai | Douai | 59507 | France |
| CHIVA | Foix | 09000 | France |
| Hôpital de Freyming | Freyming Merleback | 57804 | France |
| Centre Hospitalier | Haguenau | 67504 | France |
| Hôpital Corention Celton | Issy-les-Moulineaux | 92133 | France |
| CHD Les Oudairies | La Roche-sur-Yon | 85925 | France |
| CH Le Mans | Le Mans | 72000 | France |
| Cabinet Medical | Lille | 59000 | France |
| Hôpital Dupuytren | Limoges | 87042 | France |
| Cabinet Médical | Lunéville | 54300 | France |
| Hôpital jacques Monod | Montivilliers | 76290 | France |
| CHU Caremeau | Nîmes | 30900 | France |
| Hôpital lariboisiere | Paris | 75475 | France |
| CHRU La Miletrie | Poitiers | 86021 | France |
| CH Cornouailles | Quimper | 29107 | France |
| Clinique Mathilde | Rouen | 76175 | France |
| Hôpital de Saint Gaudens | Saint-Gaudens | 31806 | France |
| Centre hospitalier intercommunal | Saint-Germain-en-Laye | 78105 | France |
| Cabinet Medical | Sarrebourg | 57400 | France |
| HIA Sainte Anne | Toulon | 83000 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| CHRU Tours | Tours | 37044 | France |
| CH | Valenciennes | 59322 | France |
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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