Effect of Compressive Therapies on the Healing of Venous Ulcers
VENOS
1 other identifier
interventional
61
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2020
CompletedFirst Submitted
Initial submission to the registry
December 17, 2020
CompletedFirst Posted
Study publicly available on registry
January 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2023
CompletedSeptember 28, 2023
September 1, 2023
2.1 years
December 17, 2020
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
The effects of the therapies at the level of pain
On first day and in every two weeks, during 26 weeks.
Cost-effectiveness of the therapies
26 weeks
Health-related quality of life
On first day, on the 12ª week and on the 26ª week.
The effects of the therapies at the tissue integrity
On first day and in every two weeks, during 26 weeks.
Study Arms (2)
Monolayer high compression elastic bandage
EXPERIMENTALAn elastic bandage of cotton, viscose, nylon and elastane
Unna boot
ACTIVE COMPARATORA wet bandage with zinc oxide
Interventions
The nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks
The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unidade de Saúde Modelo
Porto Alegre, Rio Grande do Sul, Brazil
Unidade de Saúde Santa Cecília
Porto Alegre, Rio Grande do Sul, Brazil
Unidade de Saúde Santa Marta
Porto Alegre, Brazil
Related Publications (1)
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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisiane Paskulin, PhD
Federal University of Rio Grande do Sul
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2020
First Posted
January 11, 2021
Study Start
December 2, 2020
Primary Completion
December 29, 2022
Study Completion
April 20, 2023
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share