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Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care

Venous Ulcers Clinical Trial

Official title:
Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care. Randomized Clinical Trial

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a multilayer compression bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.

Clinical Trial Description

This study also compares the effectiveness of the multilayer and the crepe bandage, on healing of venous leg ulcers measured by the Resvech 2.0 scale and evaluates improvement in quality of life, measured by the Charing Cross Venous Ulcer Questionnaire (CCVUQ-e) and analyze the sociodemographic, clinical, and treatment factors associated with complete healing of venous ulcers.

Design: Multicentre, controlled, parallel group, randomized clinical trial, with blind evaluation of the response variable.

Setting: Primary Care Health Centres (Madrid). Subjects: Patients with venous leg ulcers, treated by nurses at the participating centres.

Intervention: Experimental group: multilayer compression bandage (two layers). Control group: crepe bandage.

Sample size: 216 patients (108 in each group) Variables:Main: Complete healing after 12 weeks follow-up. Secondary: Degree of healing (Resvech 2.0). Quality of life (CCVUQ-e). Adverse reactions. Related to the healing process: comorbidities, topical and systematic treatments, exercise, BMI. Prognostic factors: location, number and duration of ulcer. Sociodemographic factors Data analysis: By intention to treat. Comparative analysis of the two groups (chi-squared or t-test). Effectiveness analysis sing Kaplan-Meier, log rank test and cox regression analysis ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02364921
Study type Interventional
Source Gerencia de Atención Primaria, Madrid
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date January 31, 2018
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