Effect of Compressive Therapies on the Healing of Venous Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2023-04-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Monolayer high compression elastic bandage

An elastic bandage of cotton, viscose, nylon and elastane

Group Type EXPERIMENTAL

Dressing with monolayer high compression elastic bandage

Intervention Type PROCEDURE

The nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks

Unna boot

A wet bandage with zinc oxide

Group Type ACTIVE_COMPARATOR

Dressing with Unna boot

Intervention Type PROCEDURE

The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.

Interventions

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Dressing with monolayer high compression elastic bandage

The nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks

Intervention Type PROCEDURE

Dressing with Unna boot

The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes