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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005201-60 |
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Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes and often causes lower-extremity amputation. The aim of this study is to evaluate the effect of bemiparin as treatment of diabetic foot ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Bemiparin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemiparin | Drug | Bemiparin sodium |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| total healing with intact skin or a significant improvement defined as a reduction of ulcer area > or = 50% or one degree reduction on Wagner Classification. | 90 day |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of major bleeding and the incidence of adverse events. | 210 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JR March, MD | Getafe Hospital, E-28905 Getafe (Madrid) Spain | Study Chair |
| J Marinel-lo, MD | Mataró Hospital, E-08304 Mataro (Barcelona) Spain | Study Chair |
| R Gómez Medialdea, MD | Virgen de la Victoria Hospital, E-29010 Malaga, Spain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROATIA | Zagreb | Croatia | ||||
| POLAND |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014456 | Ulcer |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| C411345 | bemiparin |
| C079672 | Ro 11 |
| C118296 | dexketoprofen trometamol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | Sodium Chloride 0,9% |
|
|
| Warsaw |
| Poland |
| ROMANIA | Timișoara | Romania |
| RUSSIA | Saint Petersburg | Russia |
| SERBIA | Belgrade | Serbia |
| SPAIN | Madrid | Spain |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017670 |
| Sodium Compounds |