Clinical trial NCT02364921: Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care
Official title: Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcers
Keywords: venous ulcer
wound healing
compression bandages
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Fondo de Investigacion Sanitaria
name: Instituto de Salud Carlos III
First posted: 2015-02-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: degree of scarring achieved measured by Resverch 2.0
timeFrame: twelve weeks
Secondary outcomes:
measure: Quality of Life measured by Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)
timeFrame: twelve weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Carmen Folguera
Study officials:
affiliation: Gerencia Atención Primaria, Madrid
name: Maria del Carmen Folguera, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Folguera-Alvarez C, Garrido-Elustondo S, Verdu-Soriano J, Garcia-Garcia-Alcala D, Sanchez-Hernandez M, Torres-de Castro OG, Barcelo-Fidalgo ML, Martinez-Gonzalez O, Ardiaca-Burgues L, Solano-Villarrubia C, Lebracon-Cortes PR, Molins-Santos C, Fresno-Flores M, Canovas-Lago MC, Benito-Herranz LF, Garcia-Sanchez MT, Castillo-Pla O, Morcillo-San Juan MS, Ayuso-de la Torre MB, Burgos-Quintana P, Lopez-Torres-Escudero A, Ballesteros-Garcia G, Garcia-Cabeza P, de Francisco-Casado MA, Rico-Blazquez M; ECAMulticapa Group. ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol. BMC Nurs. 2016 Oct 12;15:58. doi: 10.1186/s12912-016-0179-x. eCollection 2016.