Clinical trial

Study of Non Inferiority of Product Kollagenase ®, Manufactured by Laboratory Cristália When Compared With Iruxol ®, Manufactured by Abbott Laboratory, in the Treatment of Cutaneous Ulcers

NCT00701974

Name

COLCRI0208

Description

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.

Trial arms

Trial start

2008-02-01

Estimated PCD

2008-02-01

Trial end

2008-02-01

Phase

Early phase I

Treatment

collagenase (IRUXOL)

patients will be treated with collagenase one time per day.

Arms:

collagenase (Kollagenase)

patients will be treated with collagenase one time per day.

Arms:

Size

Primary endpoint

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

Eligibility criteria

Inclusion Criteria: * Patients of both sexes aged over 18 years * people with skin ulcers of the lower limbs for at least 3 months Exclusion Criteria: * Lesion with a diameter larger than 12 cm ² * injury over 2 years of evolution; injury infected * neoplastic lesions in activity * poorly controlled diabetes mellitus * HAS poorly controlled * signs of ischemia in the limb * not offset any disease * allergic to components of formula * urticaria * pregnancy * breastfeeding * emotional disturbance

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}

Updated at

2022-11-03

1 organization

1 product

1 indication

Organization

Azidus Brasil

Product

Collagenase

Indication

Peptic Ulcer