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Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.

NCT02004626 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-07-16

No results posted yet for this study

Summary

This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind, Multicenter, National, Non-inferiority.

Its purpose is to determine the noninferiority in efficacy of an investigational product in relation to the product available in the market intended of treating pressure ulcers.

Conditions

  • Pressure Ulcer

Interventions

DRUG

Collagenase

Conduction of security tests: complete coagulation and glycosylated hemoglobin. Volunteers in childbearing age, with β-HCG (human chorionic gonadotropin) test. Verification of anthropometric data, clinical evaluation, PU evaluation, randomization and treatment start. Wash the wound with 0.9 % sterile saline solution; Apply of the investigational product directly in the devitalized tissue (necrotic tissue and Slough). Cover the wound with sterile gauze and dry transparent film. The procedures for the exchange of bandages must be done every day, twice a day until the total debridement of devitalized tissue. Photographic records.

DRUG

Kollagenase

Conduction of security tests: complete coagulation and glycosylated hemoglobin. Volunteers in childbearing age, with β-HCG (human chorionic gonadotropin) test. Verification of anthropometric data, clinical evaluation, PU evaluation, randomization and treatment start. Wash the wound with 0.9 % sterile saline solution; Apply of the investigational product directly in the devitalized tissue (necrotic tissue and Slough). Cover the wound with sterile gauze and dry transparent film. The procedures for the exchange of bandages must be done every day, twice a day until the total debridement of devitalized tissue. Photographic records.

Sponsors & Collaborators

  • Newco Trials Pesquisa Científica Ltda

    collaborator INDUSTRY

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    lead INDUSTRY

Principal Investigators

  • Norton Marcos S. Castro, Medic · Clínica Dr. Norton Sayeg Ltda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004626 on ClinicalTrials.gov