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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Venous Ulcers

Intervention / Treatment
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* Device: Two multilayer compression bandage
* Device: Crepe bandage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People With a diagnosis of chronic venous ulcer over six weeks duration. Presence of a larger Ankle Arm index (ABI) of 0.8 and less than 1.3. People Able to follow the trial own demands, able to understand the questionnaires, with no intention of moving and localizable for the duration of the study. That give written informed consent to participate Exclusion Criteria: Patients diagnosed with poorly controlled diabetes mellitus (last HbA1c greater than 7). In Antineoplastic therapy. Decompensated heart -insufficience . Dermatitis acute phase, at the time of the study. Rheumatoid-arthritis. Thrombosis Venosa (DVT) in acute phase. Patients with mixed ulcers Patients who participate simultaneously in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two-layer compression bandage<br>Two multilayer compression bandage: Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment.Measure the ankle circumference and choose the correct kit accordingly (ankle size 18-25cm or 25-32cm). Apply one to seven days | Device: Two multilayer compression bandage<br>* 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<br>* Other names: K2 Urgo;|
| Active Comparator: crepe bandage<br>Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days | Device: Crepe bandage<br>* Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of scarring achieved measured by Resverch 2.0 | degree of scarring achieved measured by the questionnaire Resverch 2.0 | twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life measured by Charing Cross Venous Ulcer Questionnaire (CCVUQ-e) | Quality of Life measured by the test Charing Cross Venous Ulcer Questionnaire (CCVUQ-e) | twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compression bandages, venous ulcer, wound healing