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Effect of Compressive Therapies on the Healing of Venous Ulcers (VENOS)

Primary Purpose

Venous Ulcers

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dressing with monolayer high compression elastic bandage
Dressing with Unna boot
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcers focused on measuring Varicose Ulcer, Compression Bandages, Wound Healing, Nursing, Primary Health Care, Intervention study, Cost-effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Unidade de Saúde Modelo
  • Unidade de Saúde Santa Cecília
  • Unidade de Saúde Santa Marta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monolayer high compression elastic bandage

Unna boot

Arm Description

An elastic bandage of cotton, viscose, nylon and elastane

A wet bandage with zinc oxide

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 17, 2020
Last Updated
September 26, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Casex Innovation in Healthcare, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT04703569
Brief Title
Effect of Compressive Therapies on the Healing of Venous Ulcers
Acronym
VENOS
Official Title
Effect of Compressive Therapies on the Healing of Venous Ulcers in Primary Health Services: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Casex Innovation in Healthcare, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcers
Keywords
Varicose Ulcer, Compression Bandages, Wound Healing, Nursing, Primary Health Care, Intervention study, Cost-effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monolayer high compression elastic bandage
Arm Type
Experimental
Arm Description
An elastic bandage of cotton, viscose, nylon and elastane
Arm Title
Unna boot
Arm Type
Active Comparator
Arm Description
A wet bandage with zinc oxide
Intervention Type
Procedure
Intervention Name(s)
Dressing with monolayer high compression elastic bandage
Intervention Description
The nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks
Intervention Type
Procedure
Intervention Name(s)
Dressing with Unna boot
Intervention Description
The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.
Primary Outcome Measure Information:
Title
Effect of the therapies on time and on the healing characteristics of venous ulcers
Description
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.
Time Frame
On first day and in every two weeks, during 26 weeks.
Secondary Outcome Measure Information:
Title
The effects of the therapies at the level of pain
Description
A blind evaluator for therapies will ask about of the pain on the first day and in every two weeks.
Time Frame
On first day and in every two weeks, during 26 weeks.
Title
Cost-effectiveness of the therapies
Description
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.
Time Frame
26 weeks
Title
Health-related quality of life
Description
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.
Time Frame
On first day, on the 12ª week and on the 26ª week.
Title
The effects of the therapies at the tissue integrity
Description
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.
Time Frame
On first day and in every two weeks, during 26 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisiane Paskulin, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Unidade de Saúde Modelo
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Unidade de Saúde Santa Cecília
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Unidade de Saúde Santa Marta
City
Porto Alegre
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Links:
URL
https://journals.cambridgemedia.com.au/wpr/volume-30-number-4/clinical-and-economic-analysis-compression-treatment-venous-leg-ulcers-clinical-trial-protocol-venos
Description
Article

Learn more about this trial

Effect of Compressive Therapies on the Healing of Venous Ulcers

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