Evaluation of the effect of Compression Stocking containing Natural Product in the treatment of Ulcers and Varicose Veins

Not Applicable

Recruiting

• Conditions: Chronic venous insufficiency; C14.907.952; I87.2

• Registration Number: RBR-5n9cmf
• Lead Sponsor: niversidade Federal de Sergipe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Volunteers with varicose veins, varicose veins plus edema, hyperpigmentation, lipodermatosclerosis, healed venous ulcer or active ulcer; age between 30 and 59 years; both genders; similar impairment of the saphenous vein

Exclusion Criteria

Volunteers with telangiectasias; cognitive alterations; diabetics; neuropaths; with erysipelas; lymphangitis; deep vein thrombosis; ulcer of non-venous origin; psychiatric disorders; demence; without speaking or understanding the Portuguese language; use of antibiotic or venoactive drugs in the last six months prior to the start of the research; sclerotherapy of lower limbs; surgical procedure; use of Unna boot, multi-layer dressing or dressing with topical medicine; children; morbidly obese; pregnant women; infants; patients at risk of pregnancy

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected Outcome 1: Healing of ulcers in the six-month period comprised in the study, verified by reduction of the size of the wound using the software Image J. The lesions with reduction greater than 70% of their total extension will be considered healed.;Expected Outcome 2: Improvement in patients' quality of life after six months of treatment. This outcome will be measured by the volunteers' responses to the Aberdeen questionnaire and the Wilcoxon test will be performed to check whether the patients achieved (p <0.05) or did not improve satisfactorily.

Secondary Outcome Measures

Name	Time	Method
Reduction of pain reported by the volunteer in the EVA questionnaire. This outcome will be measured according to the patients' responses using the Wilcoxon test to check whether the patients achieved (p <0.05) or did not improve satisfactorily.