NCT02364921

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Gerencia de Atención Primaria, Madrid · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Venous Ulcers

Interventions

Type	Name	Description
DEVICE	Two multilayer compression bandage	Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment. Compression therapy: a multilayer compression bandage with two layers, suitable for the treatment of venous leg ulcers and to reduce edema chronic venous be used. Apply one two seven days
DEVICE	Crepe bandage	Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2015-02-18
• Last updated: 2018-09-10

Locations

1 site across 1 country: Spain