Venous UlcersNCT02364921
Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care
A study testing Two multilayer compression bandage and Crepe bandage in people with Venous Ulcers, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effectiveness of a multilayer compression bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcers
- What is being tested?
- Two multilayer compression bandage and Crepe bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to 31 Jan 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People With a diagnosis of chronic venous ulcer over six weeks duration.
- Presence of a larger Ankle Arm index (ABI) of 0.8 and less than 1.3.
- People Able to follow the trial own demands, able to understand the questionnaires, with no intention of moving and localizable for the duration of the study.
- That give written informed consent to participate
Who cannot join
- Patients diagnosed with poorly controlled diabetes mellitus (last HbA1c greater than 7).
- In Antineoplastic therapy.
- Decompensated heart -insufficience .
- Dermatitis acute phase, at the time of the study.
- Rheumatoid-arthritis.
- Thrombosis Venosa (DVT) in acute phase.
- Patients with mixed ulcers
- Patients who participate simultaneously in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care. Randomized Clinical Trial
The purpose of this study is to evaluate the effectiveness of a multilayer compression bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.
Read the detailed description
This study also compares the effectiveness of the multilayer and the crepe bandage, on healing of venous leg ulcers measured by the Resvech 2.0 scale and evaluates improvement in quality of life, measured by the Charing Cross Venous Ulcer Questionnaire (CCVUQ-e) and analyze the sociodemographic, clinical, and treatment factors associated with complete healing of venous ulcers.
Design: Multicentre, controlled, parallel group, randomized clinical trial, with blind evaluation of the response variable.
Setting: Primary Care Health Centres (Madrid). Subjects: Patients with venous leg ulcers, treated by nurses at the participating centres.
Intervention: Experimental group: multilayer compression bandage (two layers). Control group: crepe bandage.
Sample size: 216 patients (108 in each group) Variables:Main: Complete healing after 12 weeks follow-up. Secondary: Degree of healing (Resvech 2.0). Quality of life (CCVUQ-e). Adverse reactions. Related to the healing process: comorbidities, topical and systematic treatments, exercise, BMI. Prognostic factors: location, number and duration of ulcer. Sociodemographic factors Data analysis: By intention to treat. Comparative analysis of the two groups (chi-squared or t-test). Effectiveness analysis sing Kaplan-Meier, log rank test and cox regression analysis
- Conditions
- Venous Ulcers
- Being tested
- Two multilayer compression bandage, Crepe bandage
- Keywords
- venous ulcer, wound healing, compression bandages
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two multilayer compression bandageDevice
Also called K2 Urgo
Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment.
Compression therapy: a multilayer compression bandage with two layers, suitable for the treatment of venous leg ulcers and to reduce edema chronic venous be used. Apply one two seven days
Crepe bandageDevice
Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days
| Study group | Role | What they receive |
|---|---|---|
| Two-layer compression bandage | Experimental | Two multilayer compression bandage: Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment.Measure the ankle circumference and choose the correct kit accordingly (ankle size 18-25cm or 25-32cm). Apply one to seven days Receives: Device: Two multilayer compression bandage |
| crepe bandage | Active comparator | Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days Receives: Device: Crepe bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of scarring achieved measured by Resverch 2.0
degree of scarring achieved measured by the questionnaire Resverch 2.0
Measured: twelve weeks
Secondary outcomes (1)
Quality of Life measured by Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)
Quality of Life measured by the test Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJun 2014
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
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.
- 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
- Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Fondo de Investigacion Sanitaria, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Maria del Carmen Folguera, Nurse, Principal investigator, Gerencia Atención Primaria, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364921
- Sponsor's protocol ID
- PI13/01975
- Status last verified
- Sep 2018
- First submitted
- 5 Feb 2015
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Folguera-Alvarez C, Garrido-Elustondo S, Verdu-Soriano J, Garcia-Garcia-Alcala D, Sanchez-Hernandez M, Torres-de Castro OG, Barcelo-Fidalgo ML, Martinez-Gonzalez O, Ardiaca-Burgues L, Solano-Villarrubia C, Lebracon-Cortes PR, Molins-Santos C, Fresno-Flores M, Canovas-Lago MC, Benito-Herranz LF, Garcia-Sanchez MT, Castillo-Pla O, Morcillo-San Juan MS, Ayuso-de la Torre MB, Burgos-Quintana P, Lopez-Torres-Escudero A, Ballesteros-Garcia G, Garcia-Cabeza P, de Francisco-Casado MA, Rico-Blazquez M; ECAMulticapa Group. ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol. BMC Nurs. 2016 Oct 12;15:58. doi: 10.1186/s12912-016-0179-x. eCollection 2016.
PubMed 27752238
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02364921
- Acronym / sponsor ID
- PI13/01975
- Conditions
- Venous Ulcers
- Keywords
- venous ulcer, wound healing, compression bandages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Fondo de Investigacion Sanitaria, Instituto de Salud Carlos III
- Study start
- Jun 2014 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 18 Feb 2015 (estimated)
- 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 purpose of this study is to evaluate the effectiveness of a multilayer compression bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.
Detailed description
This study also compares the effectiveness of the multilayer and the crepe bandage, on healing of venous leg ulcers measured by the Resvech 2.0 scale and evaluates improvement in quality of life, measured by the Charing Cross Venous Ulcer Questionnaire (CCVUQ-e) and analyze the sociodemographic, clinical, and treatment factors associated with complete healing of venous ulcers.
Design: Multicentre, controlled, parallel group, randomized clinical trial, with blind evaluation of the response variable.
Setting: Primary Care Health Centres (Madrid). Subjects: Patients with venous leg ulcers, treated by nurses at the participating centres.
Intervention: Experimental group: multilayer compression bandage (two layers). Control group: crepe bandage.
Sample size: 216 patients (108 in each group) Variables:Main: Complete healing after 12 weeks follow-up. Secondary: Degree of healing (Resvech 2.0). Quality of life (CCVUQ-e). Adverse reactions. Related to the healing process: comorbidities, topical and systematic treatments, exercise, BMI. Prognostic factors: location, number and duration of ulcer. Sociodemographic factors Data analysis: By intention to treat. Comparative analysis of the two groups (chi-squared or t-test). Effectiveness analysis sing Kaplan-Meier, log rank test and cox regression analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-layer compression bandage | Experimental | Device: Two multilayer compression bandageTwo multilayer compression bandage: Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment.Measure the ankle circumference and choose the correct kit accordingly (ankle size 18-25cm or 25-32cm). Apply one to seven days |
| crepe bandage | Active comparator | Device: Crepe bandageCrepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People With a diagnosis of chronic venous ulcer over six weeks duration.
- Presence of a larger Ankle Arm index (ABI) of 0.8 and less than 1.3.
- People Able to follow the trial own demands, able to understand the questionnaires, with no intention of moving and localizable for the duration of the study.
- That give written informed consent to participate
Key exclusion criteria (8 listed)
- Patients diagnosed with poorly controlled diabetes mellitus (last HbA1c greater than 7).
- In Antineoplastic therapy.
- Decompensated heart -insufficience .
- Dermatitis acute phase, at the time of the study.
- Rheumatoid-arthritis.
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 |
|---|---|---|
| Two multilayer compression bandageAlso: K2 UrgoUsual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment. Compression therapy: a multilayer compression bandage with two layers, suitable for the treatment of venous leg ulcers and to reduce edema chronic venous be used. Apply one two seven days | Device | Two-layer compression bandage |
| Crepe bandageCrepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days | Device | crepe bandage |
Primary outcome
degree of scarring achieved measured by Resverch 2.0
Time frame: twelve weeks
degree of scarring achieved measured by the questionnaire Resverch 2.0
1 secondary outcome
Quality of Life measured by Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)
Time frame: twelve 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 10 Sep 2018.
- Derived from this study: PubMed 27752238Folguera-Alvarez C, Garrido-Elustondo S, Verdu-Soriano J, Garcia-Garcia-Alcala D, Sanchez-Hernandez M, Torres-de Castro OG, Barcelo-Fidalgo ML, Martinez-Gonzalez O, Ardiaca-Burgues L, Solano-Villarrubia C, Lebracon-Cortes PR, Molins-Santos C, Fresno-Flores M, Canovas-Lago MC, Benito-Herranz LF, Garcia-Sanchez MT, Castillo-Pla O, Morcillo-San Juan MS, Ayuso-de la Torre MB, Burgos-Quintana P, Lopez-Torres-Escudero A, Ballesteros-Garcia G, Garcia-Cabeza P, de Francisco-Casado MA, Rico-Blazquez M; ECAMulticapa Group. ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol. BMC Nurs. 2016 Oct 12;15:58. doi: 10.1186/s12912-016-0179-x. eCollection 2016.
Related trials for Venous Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
Maria del Carmen Folguera, Nurse principal investigator
Gerencia Atención Primaria, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two multilayer compression bandage and Crepe bandage in people with Venous Ulcers, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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 4 inclusion and 8 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 10 Sep 2018. 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 Spain. 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?
degree of scarring achieved measured by Resverch 2.0 (time frame: twelve 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 NCT02364921, 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 10 Sep 2018.