Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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
|
Outcome Measures
Primary Outcome Measures
- degree of scarring achieved measured by Resverch 2.0 [twelve weeks]
degree of scarring achieved measured by the questionnaire Resverch 2.0
Secondary Outcome Measures
- Quality of Life measured by Charing Cross Venous Ulcer Questionnaire (CCVUQ-e) [twelve weeks]
Quality of Life measured by the test Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)
Eligibility Criteria
Criteria
Inclusion Criteria:
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People With a diagnosis of chronic venous ulcer over six weeks duration.
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Presence of a larger Ankle Arm index (ABI) of 0.8 and less than 1.3.
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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.
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That give written informed consent to participate
Exclusion Criteria:
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Patients diagnosed with poorly controlled diabetes mellitus (last HbA1c greater than 7).
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In Antineoplastic therapy.
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Decompensated heart -insufficience .
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Dermatitis acute phase, at the time of the study.
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Rheumatoid-arthritis.
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Thrombosis Venosa (DVT) in acute phase.
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Patients with mixed ulcers
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Patients who participate simultaneously in another clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carmen Folguera | Madrid | Spain | 28030 |
Sponsors and Collaborators
- Gerencia de Atención Primaria, Madrid
- Fondo de Investigacion Sanitaria
- Instituto de Salud Carlos III
Investigators
- Principal Investigator: Maria del Carmen Folguera, Nurse, Gerencia Atención Primaria, Madrid
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI13/01975