Varicose UlcerNCT06812520
Educational Intervention to Promote Compression Therapy in People With Venous Ulcer
A study testing Educational intervention in adherence in people with Varicose Ulcer, run by Alide Salazar Molina at 1 site in Chile.
Trial summary
Background: Chronic Venous Disease (CVD) is a condition that affects a significant percentage of the world's population, and can range from mild symptoms such as telangiectasias to severe manifestations such as venous ulcers (VU). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Educational intervention in adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 29 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with a grade 2 venous ulcer who is admitted to compression treatment
- Alphabet.
- Management of the Spanish language
Who cannot join
- Adult who presents a grade 1 venous ulcer
- Adult who presents cognitive impairment (determined by review of clinical record by treating nurse)
- Diagnoses of: dementia,
- Diagnoses Alzheimer's disease
- mental retardation or cognitive deficit
- Adult with severe dependency (determined by review of clinical record by treating nurse) Adult with venous ulcer with cancer undergoing chemotherapy (determined by review of clinical record by treating nurse.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Departamento de Salud de la comuna de Hualpen
Hualpén, Biobio, 4601645
Claudia A Castell, Director, 56412419957, ccastell@hualpenciudad.cl
Carolina Navarrete, nurse, 56412426787, cnavarrete@hualpenciudad.cl
About this study
Official title: Educational Intervention to Promote Compression Therapy in People With Venous Ulcer: Pilot and Non-randomized Feasibility Study
Background: Chronic Venous Disease (CVD) is a condition that affects a significant percentage of the world's population, and can range from mild symptoms such as telangiectasias to severe manifestations such as venous ulcers (VU). The gold standard UV treatment is compression therapy, however, people's adherence to it is variable due to several associated factors: physical, aesthetic and lack of education about compression therapy. Compression therapy acts by increasing interstitial pressure, thus decreasing the caliber of superficial and deep veins, decreasing venous pressure and edema . The study originates from clinical practice where it is observed that people do not adhere or abandon compression treatment, a situation that agrees with the literature review, so new trials on strategies to increase adherence are required (20). The proposed intervention: promoting adherence has a theoretical basis, a conceptual basis and an empirical basis. a) Theoretical basis: it incorporates the theory of self-care of chronic diseases with the incorporation of symptoms, due to the importance that these have for those who present them and for the self-care process, particularly with regard to maintaining self-care and adherence; in addition, the theoretical basis related to health interventions is incorporated. b) Conceptual basis: founded on vascular alterations that lead to the loss of skin integrity with the consequent imbalance: pain, edema, exudate, bad odor, so it is necessary for these to be recognized by patients and then by the professionals who serve them. c) Empirical basis: it incorporates compression therapy, considered the gold standard in the treatment of people with venous ulcers. Based on the evidence analyzed, the Lively Leg intervention developed by Heinen et al. was chosen as a basis. 2012, to which modifications were introduced based on the self-care theory, since, together, the symptoms of the ulcer, the associated chronic diseases and the characteristics of the people intervene in their adherence to compression therapy. The objective of the study is to evaluate the feasibility and preliminary effect of an educational intervention on adherence to compression therapy, pain and ulceration of the area in users who have a venous ulcer, in the commune of Hualpen, Chile, during the year 2024.
Read the detailed description
Type of study design A feasibility study will be carried out. For this purpose, a study will be carried out without a control group with a pre- and post-test comparison, since it corresponds to phase I of development of an intervention study.
Study hypotheses.
- Users who have a venous ulcer and compression therapy, after the educational intervention, have a smaller area of ulceration than at the beginning of the intervention.
- 50% of users who present venous ulcer and compression therapy show adherence to therapy after the educational intervention.
- Users who have a venous ulcer and compression therapy, after the educational intervention, have a lower intensity of pain than at the beginning of the intervention.
- Users who present with venous ulcer and compression therapy evaluate the acceptability of an educational intervention with a score greater than 2. who can participate? People over 20 years of age who have a venous ulcer, registered in the commune of Hualpen who meet the inclusion and exclusion criterio.
What are possible risks and benefits of participating? The main risk is presenting some psychoemotional alteration due to possible experiences and experiences or simply not wanting to continue, which would constitute a sufficient reason to suspend the interview, and if psychoemotional symptoms are presented, crisis care will be provided and then referred to the health Center, for your attention and which would constitute sufficient reason to suspend the interview.
The benefits of participation involve all those that are associated with ulcer healing: decrease or closure of the ulcer, decrease in pain, decrease in wound exudate, increase in control of symptoms and signs of venous ulcer, less quantity of cures, improve quality of life, greater mobility.
Patient recruitment will be carried out for convenience; the number of participants to be entered is 22, which was calculated with an estimated loss of 20%.
Recruitment of users will begin in December and is estimated to take place over 2 to 3 months.
- Conditions
- Varicose Ulcer
- Being tested
- Educational intervention in adherence
- Keywords
- Varicose ulcer, adherence, Patient education, Acceptability
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention in adherenceBehavioural
An educational intervention of 4 face-to-face sessions will be carried out as a complement to the care provided by professionals to users with venous ulcers, which consists of the advanced healing procedure that includes compressive bandaging of the venous ulcer.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention group for adherence | Experimental | The study only has the intervention group who will receive the educational activity to improve adherence to compression therapy. Receives: Behavioral: Educational intervention in adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability assessment will be carried out by applying the TAP scale
Acceptability will be measured through the Questionnaire developed by Sidani "Treatment Acceptability and Preference" (TAP) adapted to Chilean Spanish.
A total scale score is computed as the mean of the four items' scores to reflect level of perceived treatment acceptability. The possible range for the total scale score is 0 to 4, with high score reflecting high acceptability
Measured: 12 weeks
Adherence to compression therapy
Adherence can be defined as the degree to which patients follow the instructions given to them by different professionals. In this study, adherence to compression therapy will be assessed on each occasion that they attend visits and those who have a percentage of adherence to therapy equal to or above 75% in the 12-week period will be categorized as adherent.
Measured: 12 weeks
area of ulceration
Surface of the wound that is open, the evaluation is carried out by measuring in centimeters the length at its greatest and width at its largest ends and then multiplying both, with this the ulceration area is obtained.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start29 Nov 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A feasibility study will be carried out. For this purpose, a study will be carried out without a control group with a pre- and post-test comparison, since it corresponds to phase I of development of an intervention study.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alide Salazar Molina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alide Salazar Molina, Universidad de Concepcion
- Investigators
- Alide A Salazar, Doctor, Study director, Universidad de Concepcion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812520
- Sponsor's protocol ID
- CEBB1659-2024
- Status last verified
- Dec 2024
- First submitted
- 1 Feb 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention to Promote Compression Therapy in People With Venous Ulcer: Pilot and Non-randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT06812520
- Acronym / sponsor ID
- CEBB1659-2024
- Conditions
- Varicose Ulcer
- Keywords
- Varicose ulcer, adherence, Patient education, Acceptability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Alide Salazar MolinaUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 6 Feb 2025 (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.
Background: Chronic Venous Disease (CVD) is a condition that affects a significant percentage of the world's population, and can range from mild symptoms such as telangiectasias to severe manifestations such as venous ulcers (VU). The gold standard UV treatment is compression therapy, however, people's adherence to it is variable due to several associated factors: physical, aesthetic and lack of education about compression therapy. Compression therapy acts by increasing interstitial pressure, thus decreasing the caliber of superficial and deep veins, decreasing venous pressure and edema . The study originates from clinical practice where it is observed that people do not adhere or abandon compression treatment, a situation that agrees with the literature review, so new trials on strategies to increase adherence are required (20). The proposed intervention: promoting adherence has a theoretical basis, a conceptual basis and an empirical basis. a) Theoretical basis: it incorporates the theory of self-care of chronic diseases with the incorporation of symptoms, due to the importance that these have for those who present them and for the self-care process, particularly with regard to maintaining self-care and adherence; in addition, the theoretical basis related to health interventions is incorporated. b) Conceptual basis: founded on vascular alterations that lead to the loss of skin integrity with the consequent imbalance: pain, edema, exudate, bad odor, so it is necessary for these to be recognized by patients and then by the professionals who serve them. c) Empirical basis: it incorporates compression therapy, considered the gold standard in the treatment of people with venous ulcers. Based on the evidence analyzed, the Lively Leg intervention developed by Heinen et al. was chosen as a basis. 2012, to which modifications were introduced based on the self-care theory, since, together, the symptoms of the ulcer, the associated chronic diseases and the characteristics of the people intervene in their adherence to compression therapy. The objective of the study is to evaluate the feasibility and preliminary effect of an educational intervention on adherence to compression therapy, pain and ulceration of the area in users who have a venous ulcer, in the commune of Hualpen, Chile, during the year 2024.
Detailed description
Type of study design A feasibility study will be carried out. For this purpose, a study will be carried out without a control group with a pre- and post-test comparison, since it corresponds to phase I of development of an intervention study.
Study hypotheses.
- Users who have a venous ulcer and compression therapy, after the educational intervention, have a smaller area of ulceration than at the beginning of the intervention.
- 50% of users who present venous ulcer and compression therapy show adherence to therapy after the educational intervention.
- Users who have a venous ulcer and compression therapy, after the educational intervention, have a lower intensity of pain than at the beginning of the intervention.
- Users who present with venous ulcer and compression therapy evaluate the acceptability of an educational intervention with a score greater than 2. who can participate? People over 20 years of age who have a venous ulcer, registered in the commune of Hualpen who meet the inclusion and exclusion criterio.
What are possible risks and benefits of participating? The main risk is presenting some psychoemotional alteration due to possible experiences and experiences or simply not wanting to continue, which would constitute a sufficient reason to suspend the interview, and if psychoemotional symptoms are presented, crisis care will be provided and then referred to the health Center, for your attention and which would constitute sufficient reason to suspend the interview.
The benefits of participation involve all those that are associated with ulcer healing: decrease or closure of the ulcer, decrease in pain, decrease in wound exudate, increase in control of symptoms and signs of venous ulcer, less quantity of cures, improve quality of life, greater mobility.
Patient recruitment will be carried out for convenience; the number of participants to be entered is 22, which was calculated with an estimated loss of 20%.
Recruitment of users will begin in December and is estimated to take place over 2 to 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A feasibility study will be carried out. For this purpose, a study will be carried out without a control group with a pre- and post-test comparison, since it corresponds to phase I of development of an intervention study.
| Arm | Type | Receives |
|---|---|---|
| Educational intervention group for adherence | Experimental | Behavioral: Educational intervention in adherenceThe study only has the intervention group who will receive the educational activity to improve adherence to compression therapy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult with a grade 2 venous ulcer who is admitted to compression treatment
- Alphabet.
- Management of the Spanish language
Key exclusion criteria (6 listed)
- Adult who presents a grade 1 venous ulcer
- Adult who presents cognitive impairment (determined by review of clinical record by treating nurse)
- Diagnoses of: dementia,
- Diagnoses Alzheimer's disease
- mental retardation or cognitive deficit
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 |
|---|---|---|
| Educational intervention in adherenceAn educational intervention of 4 face-to-face sessions will be carried out as a complement to the care provided by professionals to users with venous ulcers, which consists of the advanced healing procedure that includes compressive bandaging of the venous ulcer. | Behavioural | Educational intervention group for adherence |
Primary outcome
Acceptability assessment will be carried out by applying the TAP scale
Time frame: 12 weeks
Acceptability will be measured through the Questionnaire developed by Sidani "Treatment Acceptability and Preference" (TAP) adapted to Chilean Spanish. A total scale score is computed as the mean of the four items' scores to reflect level of perceived treatment acceptability. The possible range for the total scale score is 0 to 4, with high score reflecting high acceptability
Adherence to compression therapy
Time frame: 12 weeks
Adherence can be defined as the degree to which patients follow the instructions given to them by different professionals. In this study, adherence to compression therapy will be assessed on each occasion that they attend visits and those who have a percentage of adherence to therapy equal to or above 75% in the 12-week period will be categorized as adherent.
area of ulceration
Time frame: 12 weeks
Surface of the wound that is open, the evaluation is carried out by measuring in centimeters the length at its greatest and width at its largest ends and then multiplying both, with this the ulceration area is obtained.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- 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.
Alide A Salazar, Doctor study director
Universidad de Concepcion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in adherence in people with Varicose Ulcer, run by Alide Salazar Molina at 1 site in Chile.
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 3 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingrid X Briones, candidate for master's degree (+56973383473, ingrid.ximena.briones@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability assessment will be carried out by applying the TAP scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.