RBR-9tqcr5q
Active, not recruiting
Phase 2
Prospective, randomized, double-blind, comparative study on Healing of lower limb Stasis Ulcers between Standard Dressings and Standard Dressings with Syzygyum cumini Extract
Gilson Roberto de Araujo0 sitesDecember 28, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gilson Roberto de Araujo
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients older than 18 years; of both sexes; who have signed the informed consent form; patients with venous ulcer in the lower limb for more than two weeks; ulcer with an area greater than three cm²
Exclusion Criteria
- •Ulcer patient being treated with antibiotic (oral or injectable), or who has used antibiotic (oral or injectable) for less than two weeks; ulcers that affect muscle or tendons; pregnant women; breastfeeding women; women of childbearing potential who do not use contraception; enlarged leukocytes; ulcer culture fragment with evidence of infection; patients with systemic infection; ankle/arm pressure index (ABI) \<0\.85; patients with diseases that hinder healing: including liver, kidney, immune, rheumatic, hematological, neurological diseases, cancer (except non\-melanoma skin cancer); difficulty in doing outpatient monitoring; known allergic reaction to any of the components used in dressings; ulcer that could not be characterized as of venous origin; chronic use of corticosteroids (for more than 15 days); use of chemotherapy; edema of lower limbs from another source, other than venous; participation in any other clinical study in the past year
Outcomes
Primary Outcomes
Not specified
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