Venous UlcersVENOSNCT04703569
Effect of Compressive Therapies on the Healing of Venous Ulcers
A study testing Dressing with monolayer high compression elastic bandage and Dressing with Unna boot in people with Venous Ulcers, run by Hospital de Clinicas de Porto Alegre at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Ulcers
- What is being tested?
- Dressing with monolayer high compression elastic bandage and Dressing with Unna boot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesBrazil
- Study dates
- 2 Dec 2020to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Unidade de Saúde Modelo
Porto Alegre, Rio Grande do Sul
Unidade de Saúde Santa Cecília
Porto Alegre, Rio Grande do Sul
Unidade de Saúde Santa Marta
Porto Alegre
About this study
Official title: 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.
Read the 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
- Being tested
- Dressing with monolayer high compression elastic bandage, Dressing with Unna boot
- Keywords
- Varicose Ulcer, Compression Bandages, Wound Healing, Nursing, Primary Health Care, Intervention study, Cost-effectiveness
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dressing with monolayer high compression elastic bandageProcedure or surgery
The nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks
Dressing with Unna bootProcedure or surgery
The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Monolayer high compression elastic bandage | Experimental | An elastic bandage of cotton, viscose, nylon and elastane Receives: Procedure: Dressing with monolayer high compression elastic bandage |
| Unna boot | Active comparator | A wet bandage with zinc oxide Receives: Procedure: Dressing with Unna boot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On first day and in every two weeks, during 26 weeks.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On first day and in every two weeks, during 26 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start2 Dec 2020
- Primary completion29 Dec 2022
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous UlcersStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Casex Innovation in Healthcare, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Lisiane Paskulin, PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703569
- Sponsor's protocol ID
- 16087119.2.0000.5327
- Acronym
- VENOS
- Status last verified
- Sep 2023
- First submitted
- 17 Dec 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Compressive Therapies on the Healing of Venous Ulcers in Primary Health Services: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04703569
- Acronym / sponsor ID
- VENOS / 16087119.2.0000.5327
- Conditions
- Venous Ulcers
- Keywords
- Varicose Ulcer, Compression Bandages, Wound Healing, Nursing, Primary Health Care, Intervention study, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Casex Innovation in Healthcare, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monolayer high compression elastic bandage | Experimental | Procedure: Dressing with monolayer high compression elastic bandageAn elastic bandage of cotton, viscose, nylon and elastane |
| Unna boot | Active comparator | Procedure: Dressing with Unna bootA wet bandage with zinc oxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dressing with monolayer high compression elastic bandageThe nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks | Procedure or surgery | Monolayer high compression elastic bandage |
| Dressing with Unna bootThe nurse will be apply the therapy Unna Boot once a week, during 26 weeks. | Procedure or surgery | Unna boot |
Primary outcome
Effect of the therapies on time and on the healing characteristics of venous ulcers
Time frame: On first day and in every two weeks, during 26 weeks.
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.
4 secondary outcomes
The effects of the therapies at the level of pain
Time frame: On first day and in every two weeks, during 26 weeks.
Cost-effectiveness of the therapies
Time frame: 26 weeks
Health-related quality of life
Time frame: On first day, on the 12ª week and on the 26ª week.
The effects of the therapies at the tissue integrity
Time frame: On first day and in every two weeks, during 26 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- BackgroundCordova 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.
- ArticleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisiane Paskulin, PhD study director
Federal University of Rio Grande do Sul
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing with monolayer high compression elastic bandage and Dressing with Unna boot in people with Venous Ulcers, run by Hospital de Clinicas de Porto Alegre at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the therapies on time and on the healing characteristics of venous ulcers (time frame: On first day and in every two weeks, during 26 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.