Effect of Compressive Therapies on the Healing of Venous Ulcers

Venous Ulcers Clinical Trial

— VENOS  

Official title:

Effect of Compressive Therapies on the Healing of Venous Ulcers in Primary Health Services: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703569
• Other study ID #: 16087119.2.0000.5327
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: April 20, 2023

Study information

• Verified date: September 2023
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to compare the effect of two treatments on the healing of venous ulcers in follow-up people in two Primary Health Services, in a city in southern Brazil. The two treatments that will be tested are: (1) the high compression elastic bandage and (2) Unna boot. The two treatments are indicated for the treatment of people with venous insufficiency and who have an active ulcer. The treatment will last 26 weeks (6 months). Once a week, during 26 weeks, a nurse will perform the dressing and will apply the therapy high compression elastic bandage or Unna boot according to a drawing and in every two weeks an evaluator will assess the characteristics of the ulcers and the size.

Description:

The primary objective is to compare the effect of two compressive therapies, high compression elastic bandage and Unna boot, on time and on the healing characteristics of venous ulcers in Primary Health Care and the secondary objectives are to verify the effects of the therapies in tissue integrity and at the level of pain, to identify quality of life of the participants and to evaluate the cost-effectiveness of the two therapies from the perspective of the Unified Health System. A randomized clinical trial is being carried out in two Primary Health Services in Porto Alegre city, with people with active venous ulcer. 126 venous ulcers, 63 in each group will be followed. The A group receives elastic compressive therapy (high compression elastic bandage) and the B group receives inelastic compressive therapy (Unna boot) by randomization. Once a week, during 26 weeks, a nurse applies the therapy according to the randomization group. And a blind evaluator for therapies will assess the characteristics of the ulcers and the size, on the first day and in every two weeks until 26ª week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 20, 2023
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• people with diagnosis of chronic venous insufficiency recorded in medical records, with active venous ulcer;

• with indication of compressive therapy, who are not using any of the therapies used in the study and who have not used them within 30 days of the initial moment of data collection;

• 18 years old or older;

• with Ankle-Brachial Index (ABI) between 0.8 and 1.2;

• with pulses present on palpation in lower limbs;

• walking people;

• with Body Mass Index (BMI) between = 18.5 kg/m2 and 39.9 kg/m2 (for elderly people: = 22 kg/m2 and 39.9 kg/m2);

• with ankle circumference greater than 18cm.

Exclusion Criteria:

• pregnant women;

• people with mixed, infected or in the epithelialization phase UV (with epithelial tissue in 90% of the UV area);

• uncontrolled diabetics (with Glycated Hemoglobin greater than 7% in the last six months);

• people with medical diagnosis of dermatological, rheumatological and oncological diseases in the member of the active UV or immunosuppressive diseases (for influencing the healing process);

• with allergy to any f the components of the compressive therapies used in the study;

• people using immunosuppressants and/or corticosteroids for more than 21 days (for influencing the healing process).

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcers

Intervention

Procedure:
• Dressing with monolayer high compression elastic bandage
The nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks
• Dressing with Unna boot
The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.

Locations

Country	Name	City	State
Brazil	Unidade de Saúde Modelo	Porto Alegre	Rio Grande Do Sul
Brazil	Unidade de Saúde Santa Cecília	Porto Alegre	Rio Grande Do Sul
Brazil	Unidade de Saúde Santa Marta	Porto Alegre

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Casex Innovation in Healthcare, Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Cordova FP, Fuhrmann AC, Machado, DO, Mocellin D, Silva BU, Lucena AF, Paskulin LMG. Clinical and economic analysis on compression treatment of venous leg ulcers: clinical trial protocol VENOS. Wound Practice and Research. 2022; 30(4): 216-222.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of the therapies on time and on the healing characteristics of venous ulcers	A blind evaluator for therapies will assess the characteristics of the ulcers using a Likert scale, being 1 the worst score and 5 best score, proposed to Nursing Outcomes Classification (NOC), in the outcome Wound Healing: Secondary Intention. This outcome has indicators to assess the healing characteristics, such as granulation tissue; necrosis; epithelial tissue; exsudate; erythema; oedema; macerated skin; odor and planimetry.	On first day and in every two weeks, during 26 weeks.
Secondary	The effects of the therapies at the level of pain	A blind evaluator for therapies will ask about of the pain on the first day and in every two weeks.	On first day and in every two weeks, during 26 weeks.
Secondary	Cost-effectiveness of the therapies	Direct costs to perform the dressing will be measured through a tool built by the researches. Every week, the nurses will take notes of all products they used and the time spent to perform the dressing (using a stopwatch). This will be converted into monetary value. Besides that, a blind evaluator for therapies will assess the effectiveness through the wound planimetry. In the end, the relationship between cost-effectiveness will be calculated.	26 weeks
Secondary	Health-related quality of life	The SF-6D Questionnaire will be applied to the participants to identify the quality of life, on the first day, on the 12ª week and on the 26ª week. The Short Form-6 Dimension (SF-6D) is a widely used preference-based generic health-related quality of life measure with a multiattribute classification system consisting of six dimensions: physical functioning, role functioning, social functioning, pain, mental health, and vitality. Each dimension is composed of three to five levels. The SF-6D values range from 0.315 to 1, with higher scores indicating better health-related quality of life anchoring on the 0 (dead) to 1 (full health) scale.	On first day, on the 12ª week and on the 26ª week.
Secondary	The effects of the therapies at the tissue integrity	A blind evaluator for therapies will assess the tissue integrity using a Likert scale, being 1 the worst score and 5 best score, proposed to Nursing Outcomes Classification (NOC), in the outcome Tissue Integrity: Skin and Mucous Membranes. This outcome has indicators to assess the tissue integrity, such as necrosis; skin hydration and skin pigmentation.	On first day and in every two weeks, during 26 weeks.

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