Clinical trial NCT04703569: Effect of Compressive Therapies on the Healing of Venous Ulcers
Official title: Effect of Compressive Therapies on the Healing of Venous Ulcers in Primary Health Services: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcers
Keywords: Varicose Ulcer
Compression Bandages
Wound Healing
Nursing
Primary Health Care
Intervention study
Cost-effectiveness
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Casex Innovation in Healthcare
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2021-01-11
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Effect of the therapies on time and on the healing characteristics of venous ulcers
timeFrame: On first day and in every two weeks, during 26 weeks.
Secondary outcomes:
measure: The effects of the therapies at the level of pain
timeFrame: On first day and in every two weeks, during 26 weeks.
measure: Cost-effectiveness of the therapies
timeFrame: 26 weeks
measure: Health-related quality of life
timeFrame: On first day, on the 12ª week and on the 26ª week.
measure: The effects of the therapies at the tissue integrity
timeFrame: On first day and in every two weeks, during 26 weeks.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Unidade de Saúde Modelo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Unidade de Saúde Santa Cecília
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Unidade de Saúde Santa Marta
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Lisiane Paskulin, PhD
role: STUDY_DIRECTOR
References:
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.