Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01394-41 | Other Identifier | ID RCB Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V0111 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tested product : V0111 cream | Device | Application twice a day during 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete healing of target fissure on the heel | Comparison of the two treatment groups (verum versus placebo) | Day 28 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Garrigue, MD | Pierre Fabre Médicament | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | Belgium | |||||
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Device |
Application twice a day during 28 days |
|
| Edegem |
| Belgium |
| Liège | Belgium |
| Angers | France |
| Bron | France |
| La Rochelle | France |
| Laval | France |
| Mantes-la-Jolie | France |
| Muret | France |
| Nanterre | France |
| Nice | France |
| Nieuls Sur Mer | France |
| Paris | France |
| Pessac | France |
| Pringy | France |
| Rillieux Village | France |
| Saint-Orens-de-Gameville | France |
| Seysses | France |
| Suresnes | France |
| Tiercé | France |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided