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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01128-39 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers management when two different compression systems are used. Micro-costing during the study will bring direct costs which include nurse and physician time, dressings and bandages.
Perspective of costs will be Public Health Insurance. Time horizon will be 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compression1 | Active Comparator | Multilayer compression bandage (Profore) |
|
| Compression2 | Experimental | Coban2 compression system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profore | Device | Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Direct cost of leg ulcer management | Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of adverse events related to compression | Number and type of adverse events related to compression bandages | 16 weeks |
| Patient's compression bandage acceptance score | Four ad hoc 7-level Likert scales will be used to assess bandage impact on daily activities, sleep, shoes and slippage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Meaume, MD | AP-HP Hôpital Rothschild - Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quimper Center | Quimper | France |
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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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| Coban2 | Device | Coban2 compression system + standard regimen for wound care according to investigator's choice |
|
| 16 weeks |
| Number of patients with fully healed ulcer | Full healing rate | 16 weeks |
| EuroQoL 5D-5L change between baseline and last visit | Quality of Life | 16 weeks |
| Average time to full healing | 16 weeks |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |