NCT04703569

Effect of Compressive Therapies on the Healing of Venous Ulcers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Venous Ulcers

Interventions

Type	Name	Description
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
PROCEDURE	Dressing with Unna boot	The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-12-29
• Completion: 2023-04-20
• First posted: 2021-01-11
• Last updated: 2023-09-28

Locations

3 sites across 1 country: Brazil