Varicose veins of the lower limbs with ulcer and inflammation
Conditions
Interventions
Patients were divided into two groups at random and anonymously. The first (group A) composed of 44 participants received as treatment for their ulcer Jamelão extract gel and compression sock . The se
Sponsors
Gilson Roberto de Araujo
FUNDACAO DE APOIO A PESQUISA DO DISTRITO FEDERAL FAPDF
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe the healing of the venous ulcer until the end of the 14th visit. The result is expected to be significantly better in the group using the dressing with jamelão extract gel, from a statistical point of view | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the healing rate is expected (rate measured in percentage per month). The result is expected to be significantly better in the group using the dressing with jamelão extract gel, from a statistical point of view ;The ulcer, once healed, is expected to remain closed throughout the follow-up period. The result is expected to be significantly better in the group using the dressing with jamelão extract gel, from a statistical point of view;It is expected that the patient will improve his quality of life, measured through a questionnaire validated in the medical literature and aimed at patients with venous ulcers. The total scores of the questionnaire ranging from 0 to 100, in which higher values indicate a poorer quality of life.The result is expected to be significantly better in the group using the dressing with jamelão extract gel, from a statistical point of view;It is expected to observe local pain levels, measured using a questionnaire validated in the medical literature. Scores varying from zero to ten (zero being the absence of pain and ten being the most severe pain experienced by the patient). The result is expected to be significantly better in the group using the dressing with jamelão extract gel, from a statistical point of view | — |
Countries
Brazil
Contacts
Public ContactGilson Araújo
Outcome results
None listed