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

Gerencia de Atención Primaria, Madrid

Status: Completed

Conditions: Venous Ulcers

Treatments: Device: Two multilayer compression bandage; Device: Crepe bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT02364921

PI13/01975

Details and patient eligibility

About

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.

Full 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

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Two-layer compression bandage

Experimental group

Description:

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

Treatment:

Device: Two multilayer compression bandage

crepe bandage

Active Comparator group

Description:

Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days

Treatment:

Device: Crepe bandage