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| ID | Type | Description | Link |
|---|---|---|---|
| COLCRI0208 | Other Identifier | Protocol |
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Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes.
Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | patients treated with collagenase (IRUXOL) |
|
| 2 | Experimental | patients treated with collagenase (Kollagenase) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagenase (IRUXOL) | Biological | patients will be treated with collagenase one time per day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events. | healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal Clinica | Valinhos | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017364 | Collagenases |
| C005519 | iruxol |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| collagenase (Kollagenase) |
| Biological |
patients will be treated with collagenase one time per day. |
|
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |