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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Ulcers
• Intervention / Treatment: Procedure: Dressing with monolayer high compression elastic bandage; Procedure: Dressing with Unna boot

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisiane Paskulin, PhD; Phone Number: 55 51 3308-5226; Email: paskulin@orion.ufrgs.br

Study Locations

• Brazil
  • Porto Alegre, Brazil
    • Unidade de Saúde Santa Marta
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Unidade de Saúde Modelo
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Unidade de Saúde Santa Cecília

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monolayer high compression elastic bandage; An elastic bandage of cotton, viscose, nylon and elastane	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
Active Comparator: Unna boot; A wet bandage with zinc oxide	Procedure: Dressing with Unna boot; The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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.
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.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Casex Innovation in Healthcare
• Investigators: Study Director: Lisiane Paskulin, PhD, Federal University of Rio Grande do Sul

Publications and helpful links

General Publications

• 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.

Helpful Links

• Article

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): December 29, 2022
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Primary Health Care; Wound Healing; Nursing; Cost-effectiveness; Compression Bandages; Varicose Ulcer; Intervention study
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer
• Other Study ID Numbers: 16087119.2.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No