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

Venous Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364921
• Other study ID #: PI13/01975
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2018
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcers

Intervention

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

Locations

Country	Name	City	State
Spain	Carmen Folguera	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Fondo de Investigacion Sanitaria, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of scarring achieved measured by Resverch 2.0	degree of scarring achieved measured by the questionnaire Resverch 2.0	twelve weeks
Secondary	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