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Completed

NCT Number: NCT02364921

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

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.

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Key information

Conditions

Venous Ulcers Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmen Folguera

Madrid, 28030, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Two multilayer compression bandage

Device

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

Other names: K2 Urgo

Crepe bandage

Device

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

Primary outcomes

  1. degree of scarring achieved measured by Resverch 2.0

    Time frame: twelve weeks

    degree of scarring achieved measured by the questionnaire Resverch 2.0

Secondary outcomes

  1. Quality of Life measured by Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)

    Time frame: twelve weeks

    Quality of Life measured by the test Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

  • Fondo de Investigacion Sanitaria
  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2015
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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