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

September 7, 2018 updated by: Gerencia de Atención Primaria, Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28030
        • Carmen Folguera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Two-layer compression bandage
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of scarring achieved measured by Resverch 2.0
Time Frame: twelve weeks
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)
Time Frame: twelve weeks
Quality of Life measured by the test Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)
twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerencia de Atención Primaria, Madrid

Collaborators

Fondo de Investigacion Sanitaria
Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Maria del Carmen Folguera, Nurse, Gerencia Atención Primaria, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI13/01975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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