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| ID | Type | Description | Link |
|---|---|---|---|
| 02H37 | Other Identifier | CPP Nord-Ouest II |
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| Name | Class |
|---|---|
| Institut de Recherches Internationales Servier | OTHER |
| Société de Dermatologie Française | OTHER |
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This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional arm | Experimental | Psychological tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological tests | Other | social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status |
| Measure | Description | Time Frame |
|---|---|---|
| Healing or non-healing of venous leg ulcers at week 24 | Healing or non-healing of venous leg ulcers at week 24 | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical characteristics | comparison between healed and non healed venous leg ulcers at week 24 for patient clinical characteristics (age, weight, body mass index, concomitant diseases, medical and surgical history, autonomy, mobility) | week 24 |
| biologic characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine LOK, PhD | Centre Hospitalo-Universitaire d'Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalo-Universitaire d'Amiens - Dermatologie | Amiens | 80000 | France | |||
| Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23909381 | Result | Chaby G, Senet P, Ganry O, Caudron A, Thuillier D, Debure C, Meaume S, Truchetet F, Combemale P, Skowron F, Joly P, Lok C; Angio-Dermatology Group of the French Society of Dermatology. Prognostic factors associated with healing of venous leg ulcers: a multicentre, prospective, cohort study. Br J Dermatol. 2013 Nov;169(5):1106-13. doi: 10.1111/bjd.12570. |
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comparison between healed and non healed venous leg ulcers at week 24 for patient biologic characteristics (complete blood count, hemoglobinemia, albuminemia, and only for patients with diabetes mellitus : glycemia and glycated haemoglobin) |
| week 24 |
| psychologic assessments | comparison between healed and non healed venous leg ulcers at week 24 for patient psychologic assessments (self-esteem assessed by Coopersmith self-esteem inventory, symptoms of depression researched with Beck Depression Inventory) | week 24 |
| cognitive assessments | comparison between healed and non healed venous leg ulcers at week 24 for patient cognitive assessments (intellectual quotient evaluated by Raven's progressives matrices test, signs of intellectual deterioration assessed by Minimal Mental Status test) | week 24 |
| social assessment | comparison between healed and non healed venous leg ulcers at week 24 for patient social assessments (assessment of social and occupational group, of education level, of income level and of marital status) | week 24 |
| affected-leg characteristics | comparison between healed and non healed venous leg ulcers at week 24 for patient affected-leg inclusion characteristics (venous insufficiency classified using CEAP classification, ultrasonography assessment of leg with measurement of the Ankle Brachial Index (ABI) and examination of the leg venous system, number of ulcers on target leg, presence/absence of venous abnormalities (varicose veins, ochre dermatitis, white atrophy, acute hypodermitis), of cutaneous signs of lymphatic insufficiency, of oedema and of ankle articulation ankylosis) | week 24 |
| venous leg ulcers inclusion characteristics | comparison between healed and non healed venous leg ulcers at week 24 for patient venous leg ulcers inclusion characteristics (size, localization, duration, percentage of granulation/fibrinous tissue, aspect of ulcer's margins, pain) | week 24 |
| venous insufficiency treatment | comparison between healed and non healed venous leg ulcers at week 24 for patient venous insufficiency treatment (compliance to venous contention assessed by an evaluating questionnaire) | week 24 |
| Amiens |
| 80000 |
| France |
| Hôpital Victor Dupouy - Dermatologie | Argenteuil | 95100 | France |
| Hôpital Saint Jacques - Dermatologie 1 | Besançon | 25030 | France |
| CHU de Brest - Dermatologie | Brest | 29609 | France |
| CHU Clémenceau - Dermatologie | Caen | 14033 | France |
| Hôpitaux Civils de Colmar - Service de Dermatologie | Colmar | 68024 | France |
| CHU Bocage - Dermatologie | Dijon | 21034 | France |
| CHU Michallon - Dermatologie | Grenoble | 38043 | France |
| Hôpital C. Foix - Service de Gérontologie | Ivry | 94205 | France |
| Centre Hospitalier - Service de Médecine Interne | Lens | 62307 | France |
| Hôpital Robert Boulin - Dermatologie | Libourne | 33500 | France |
| Hôpital Claude Huriez - Clinique Dermatologique | Lille | 59037 | France |
| CHRU Dupuytren - Dermatologie | Limoges | 87042 | France |
| Hôpital Saint Philibert - Dermatologie | Lomme | 59462 | France |
| Hôpital d'Instruction des Armées Desgenettes | Lyon | 69998 | France |
| Hôpital Sainte Marguerite - Dermatologie | Marseille | 13009 | France |
| Hôpital SAint Charles - Dermatologie | Montpellier | 34295 | France |
| Hôpital Fournier | Nancy | 54000 | France |
| Hôpital Rothschild - Consultation de Dermatologie | Paris | 75012 | France |
| CHU Bichat - Service de Dermatologie | Paris | 75018 | France |
| Hôpital Saint Louis - Service de Dermatologie | Paris | 75475 | France |
| Hôpital Broussais - Rééducation Vasculaire | Paris | 75674 | France |
| Hôpital du Haut Levêque - Dermatologie | Pessac | 33604 | France |
| Centre Hospitalier Laennec - Dermatologie | Quimper | 29107 | France |
| CHU Robert Debré | Reims | 51092 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| Cabinet de Dermatologie 43, rue Jean Lecanuet | Rouen | 76000 | France |
| Hôpital Charles NICOLLE - Service de Dermatologie | Rouen | 76031 | France |
| Le Royal Parc - Dermatologie | Saint-Brieuc | 22000 | France |
| Centre Hospitalier Intercommunal Poissy Saint Germain | Saint-Germain-en-Laye | 78100 | France |
| Cabinet de Dermatologie 1,rue dembarrère | Tarbes | 65000 | France |
| Hôpital Beauregard | Thionville | 57100 | France |
| CHU Trousseau - Dermatologie | Tours | 37044 | France |
| Centre Hospitalier de Valence - Dermatologie | Valence | 26000 | France |
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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