Varicose UlcerACTIVE_LEGSNCT04039789
Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care.
A study testing Project active legs in people with Varicose Ulcer, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
Objectives: To evaluate the effectiveness of a structured educational intervention in physical exercise "Active Legs" as an adjuvant treatment to improve the healing of chronic venous ulcers at 3 months of follow-up, compared with the usual practice in people treated in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Project active legs
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2021to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a diagnosis of venous ulcers registered in electronic clinical history (history of chronic venous insufficiency and/or venous ulcer) and presence of an ankle brachial index (ABI) greater than 0.8 and less than 1.3.
- Presence at least a venous ulcer of 1cm or more in diameter. If the participant has more than one lesion, the nurse will select the lesion with the highest Resvech 2.0 score for the study.
- Independent ambulation or with the help of devices.
- Individuals who able to follow the demands of the trial and who provide their written informed consent to participate.
Who cannot join
- Patients with mixed ulcers.
- Acute phase deep vein thrombosis.
- Patients on treatment with antineoplastic agents.
- Decompensated heart failure.
- Rheumatoid arthritis.
- Acute phase dermatitis, at the time of the study.
Show all 9Show fewer
- Patients immobilized at home, institutionalized or displaced residing outside the area where the research is conducted for more than 6 months a year or during the performance of the intervention.
- Absolute contraindication to perform physical exercise.
- Patients who are simultaneously participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care: Multicenter Randomized Clinical Trial - Active Legs Project
Objectives: To evaluate the effectiveness of a structured educational intervention in physical exercise "Active Legs" as an adjuvant treatment to improve the healing of chronic venous ulcers at 3 months of follow-up, compared with the usual practice in people treated in primary care. Secondary objectives: To evaluate if the intervention active legs as an adjuvant treatment produces better results than usual practice in: degree of healing, recurrence, complete healing at 6 months, pain and quality of life. Describe degree of adherence and satisfaction with the intervention. Design: Randomized, multicenter, pragmatic, open clinical trial of parallel groups with 6 months of follow-up. Setting: Primary Care Health Centers (Madrid). Subjects: Patients with venous ulcers, with treatment in the nursing consultation of the participating centers. Sample: 224 participants (112 in each group). Intervention: Both groups will receive the usual treatment of cleaning, debridement based on humid environment cure and multilayer compression therapy according to the recommendations of Community of Madrid. The intervention group will also receive the structured educational intervention of lower limbs physical exercise and daily walking patterns. Variables: Main: complete healing at 3 months follow-up. Secondary: Degree of healing; ulcer area; quality of life; pain, related to the healing process, prognosis and recurrences; Sociodemographic and related adherence and satisfaction. Data analysis: Main effectiveness: comparison of the incidence of ulcers with complete healing at 3 months of follow-up in both groups, time to complete healing (Kaplan-Meier and Log-rank test). Adjustment of prognostic factors (Cox regression).
- Conditions
- Varicose Ulcer
- Being tested
- Project active legs, Usual care
- Keywords
- Varicose ulcer, Exercise, Nurses, Healthy Aging
- Medical subject headings
- Varicose Ulcer, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project active legsBehavioural
Home program of exercises of lower extremities includes the performance of 4 exercises of lower extremities of progressive difficulty that must be carried out at home 5 days a week, twice a day and walking progressively until reaching the marked goal (150 min / week (30 minutes for 5 days a week)).
Usual careProcedure or surgery
Evaluation, cleaning, debridement, topical treatment (moist healing) and compressive therapy according to the recommendations for the treatment of chronic cutaneous ulcers of the Community of Madrid.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Usual Care: that consists of healing the wound (assessment, cleaning, disinfection, debridement and topical treatment) and compression therapy multilayer usual practice, according to the recommendations for the treatment of cutaneous ulcers of the Region of Madrid. Receives: Procedure: Usual care |
| Intervention | Experimental | ACTIVE LEGS: The usual care plus experimental intervention. It is a structured educational intervention, directed by nurses and carried out in the health center consultations. The intervention "Active Legs" has been designed based on the available evidence. It incorporates a program of lower limb exercise at home and daily walking patterns.
Home program of lower limb exercises. The nurse will instruct the patients in the performance of 4 exercises of lower limbs of progressive difficulty that must be performed at home 5 days a week, twice a day Daily walking program. In addition, patients must ambulate progressively until reaching the marked goal (150 min / week (30 minutes for 5 days a week)) .
At the start of the study, the "Active Legs" diary will be provided, showing the patterns of the exercise and walking program graphically and a pedometer. Receives: Behavioral: Project active legs; Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing at 6 months of follow-up
(yes/no) (complete and sustained epithelialisation for at least 2 weeks).
Measured: 6 months
Time elapsed between start of the study and complete healing of the wound
(in days)
Measured: 6 months
Secondary outcomes (29)
Degree of healing (Resvech 2.0)
The questionnaire consists of 6 dimensions with ascending scoring scales according to the severity of the dimension studied. It is divided into: depth (0 to 4), size (0 to 6), borders (0 to 4), wound bed (0 to 4), exudate (0 to 3) and signs and symptoms of infection (0 to 14). The total score ranges from 0 to 35.
Measured: Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
Ulceral area
In cm2. Measured by digital photography. Measurement through digital photography and subsequent treatment of the image using the open source Java image processing program "The ImageJ ecosystem" and its subsequent calculation using the Visitrack device.
Measured: Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
Health-related quality of life for patients with venous ulcers (CCVUQ-e)
It is a questionnaire that measures quality of life in patients with venous ulcers. In addition to a global synthetic quality of life score, it has 4 dimensions: Social interaction, Cosmesis (body image), Emotional state and Domestic activities. Both the general score and the dimensions have a score that ranges from 0 to 100, where 0 is the best quality of life and 100 the worst quality of life.
Measured: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Perceived pain: visual analogical scale of the McGill questionnaire
The visual analogical scale of the McGill questionnaire will be used. A greater than 20mm in the Visual Analog Scale of pain scale will be considered a clinically significant change.
It goes from "no pain" 0 to "unbearable pain" 10, the patient will mark that point on the line that best reflects the pain he suffers.
Measured: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Level of adherence to the intervention "Active Legs". Number of steps.
Daily record using the Yamax PZ270 pedometer (15 days memory)
Measured: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Level of adherence to the intervention "Active Legs". Time.
The time in minutes / day
Measured: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Level of adherence to the intervention "Active Legs". The self-reported information by the patient of the domiciliary exercise program.
By registering in the activity diary, classifying it as "Excellent" in 75% or more of the prescribed sessions, "Good" between 50-74%, "Moderate" between 25-49% and "Poor" less than 25%.
Measured: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Age (sociodemographic variables)
in years
Measured: Measured at the beginning (baseline)
Sex (sociodemographic variables)
Male/Female
Measured: Measured at the beginning (baseline)
Living alone (sociodemographic variables)
Yes/no
Measured: Measured at the beginning (baseline)
Employment status (sociodemographic variables)
housewife / unemployed / student / worker employee account / worker own account
Measured: Measured at the beginning (baseline)
Education level (sociodemographic variables)
low / medium / high
Measured: Measured at the beginning (baseline)
Weight (variables related to the healing process)
in kilograms. weight and height will be combined to report BMI in kg/m^2
Measured: Measured at the beginning (baseline)
Height (variables related to the healing process)
in meters. weight and height will be combined to report BMI in kg/m^2
Measured: Measured at the beginning (baseline)
Underlying disease (variables related to the healing process)
(yes / no) for heart failure, renal failure, hypertension, diabetes mellitus, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, osteoarthritis, deep vein thrombosis, peripheral arterial vasculopathy, varicose veins.
Measured: Measured at the beginning (baseline)
ABI (variables related to the healing process)
The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).
Measured: Measured at the beginning (baseline)
Tobacco consumption (variables related to the healing process)
no smoker / smoker / ex-smoker
Measured: Measured at the beginning (baseline)
Alcohol consumption (variables related to the healing process)
volume grams of alcohol / week
Measured: Measured at the beginning (baseline)
Topical and systemic treatment (variables related to the healing process)
(yes/no) for hydrocellular dressings, alginates, hydrogels, collagenase, silver dressings, low adhesion dressings, silver sulfadiazine in ointment, other antibiotics in ointment, moisturizing products for the skin.
Measured: Measured at the beginning (baseline)
Adherence to multilayer compression therapy (variables related to the healing process)
(yes/no)
Measured: Measured at the beginning (basal) and fortnightly until 3 months and at 6 months .
Physical activity level measured by the Minnesota free time physical activity questionnaire (variables related to the healing process)
It allows to measure the energy expenditure during free time and allows to classify individuals in activity categories. In metabolic energy turnover (METS)-min/14 days. Interpreting as: very active above 5000 METS-min / 14 days, Active between 3000 and 4999 METS-min / 14 days, Moderately active between 1250 and 2999 METS-min / 14 days and sedentary less than 1250 METS-min / 14 days .
Measured: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Type of daily walking (variables related to the healing process)
Independent / Independent with technical assistance (cane, crutches or walker with or without wheels) / With the help of the participation of a person without technical assistance / With the help of the participation of a person with technical help
Measured: Measured at the beginning (baseline)
Location of the ulcer (prognostic variables)
internal lateral aspect/ supra-malleolar area/ anterior area of the leg/ external lateral aspect of the leg/ posterior aspect of the leg
Measured: Measured at the beginning (baseline)
Number of ulcers at the time of the study (prognostic variables)
in number
Measured: Measured at the beginning (baseline)
Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)
in days
Measured: Measured at the beginning (baseline)
Recurrent ulcer (prognostic variables)
(yes/no)
Measured: Measured at the beginning (baseline)
Recurrence (variables related to recurrences)
(yes / no)
Measured: measured at 6 months of follow-up
Use of compression stockings (variables related to recurrences)
(Yes/no) for Light / normal / strong compression
Measured: measured at 6 months of follow-up
Hydration of the legs (variables related to recurrences)
(Yes/no)
Measured: measured at 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start17 May 2021
- Primary completion10 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, multicentre clinical trial, parallel, pragmatic, with 6 months of follow-up.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Borja Jesús Herraiz Ahijado, Gerencia de Atención Primaria, Madrid
- Investigators
- Borja Jesús Herraiz Ahijado, Nurse, Principal investigator, Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039789
- Sponsor's protocol ID
- CCI 11/18
- Acronym
- ACTIVE_LEGS
- Status last verified
- Mar 2024
- First submitted
- 11 Jul 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herraiz-Ahijado B, Folguera-Alvarez C, Rodriguez-Barrientos R, Sanchez-Ruano R, Pascual-Garcia M, Mori-Vara P, Verdu-Soriano J, Rico-Blazquez M; Active Legs Group. Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: active legs RCT. BMC Nurs. 2025 Dec 10;25(1):38. doi: 10.1186/s12912-025-04189-0.
PubMed 41372918Herraiz-Ahijado B, Folguera-Alvarez C, Verdu-Soriano J, Mori-Vara P, Rico-Blazquez M. Active legs: Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: a RCT protocol study. BMC Nurs. 2023 Mar 10;22(1):65. doi: 10.1186/s12912-023-01214-y.
PubMed 36899351
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care: Multicenter Randomized Clinical Trial - Active Legs Project
- ClinicalTrials.gov ID
- NCT04039789
- Acronym / sponsor ID
- ACTIVE_LEGS / CCI 11/18
- Conditions
- Varicose Ulcer
- Keywords
- Varicose ulcer, Exercise, Nurses, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- 17 May 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Jul 2019 (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.
Objectives: To evaluate the effectiveness of a structured educational intervention in physical exercise "Active Legs" as an adjuvant treatment to improve the healing of chronic venous ulcers at 3 months of follow-up, compared with the usual practice in people treated in primary care. Secondary objectives: To evaluate if the intervention active legs as an adjuvant treatment produces better results than usual practice in: degree of healing, recurrence, complete healing at 6 months, pain and quality of life. Describe degree of adherence and satisfaction with the intervention. Design: Randomized, multicenter, pragmatic, open clinical trial of parallel groups with 6 months of follow-up. Setting: Primary Care Health Centers (Madrid). Subjects: Patients with venous ulcers, with treatment in the nursing consultation of the participating centers. Sample: 224 participants (112 in each group). Intervention: Both groups will receive the usual treatment of cleaning, debridement based on humid environment cure and multilayer compression therapy according to the recommendations of Community of Madrid. The intervention group will also receive the structured educational intervention of lower limbs physical exercise and daily walking patterns. Variables: Main: complete healing at 3 months follow-up. Secondary: Degree of healing; ulcer area; quality of life; pain, related to the healing process, prognosis and recurrences; Sociodemographic and related adherence and satisfaction. Data analysis: Main effectiveness: comparison of the incidence of ulcers with complete healing at 3 months of follow-up in both groups, time to complete healing (Kaplan-Meier and Log-rank test). Adjustment of prognostic factors (Cox regression).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, multicentre clinical trial, parallel, pragmatic, with 6 months of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Usual careUsual Care: that consists of healing the wound (assessment, cleaning, disinfection, debridement and topical treatment) and compression therapy multilayer usual practice, according to the recommendations for the treatment of cutaneous ulcers of the Region of Madrid. |
| Intervention | Experimental | Behavioral: Project active legs, Procedure: Usual careACTIVE LEGS: The usual care plus experimental intervention. It is a structured educational intervention, directed by nurses and carried out in the health center consultations. The intervention "Active Legs" has been designed based on the available evidence. It incorporates a program of lower limb exercise at home and daily walking patterns. Home program of lower limb exercises. The nurse will instruct the patients in the performance of 4 exercises of lower limbs of progressive difficulty that must be performed at home 5 days a week, twice a day Daily walking program. In addition, patients must ambulate progressively until reaching the marked goal (150 min / week (30 minutes for 5 days a week)) . At the start of the study, the "Active Legs" diary will be provided, showing the patterns of the exercise and walking program graphically and a pedometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with a diagnosis of venous ulcers registered in electronic clinical history (history of chronic venous insufficiency and/or venous ulcer) and presence of an ankle brachial index (ABI) greater than 0.8 and less than 1.3.
- Presence at least a venous ulcer of 1cm or more in diameter. If the participant has more than one lesion, the nurse will select the lesion with the highest Resvech 2.0 score for the study.
- Independent ambulation or with the help of devices.
- Individuals who able to follow the demands of the trial and who provide their written informed consent to participate.
Key exclusion criteria (9 listed)
- Patients with mixed ulcers.
- Acute phase deep vein thrombosis.
- Patients on treatment with antineoplastic agents.
- Decompensated heart failure.
- 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 |
|---|---|---|
| Project active legsHome program of exercises of lower extremities includes the performance of 4 exercises of lower extremities of progressive difficulty that must be carried out at home 5 days a week, twice a day and walking progressively until reaching the marked goal (150 min / week (30 minutes for 5 days a week)). | Behavioural | Intervention |
| Usual careEvaluation, cleaning, debridement, topical treatment (moist healing) and compressive therapy according to the recommendations for the treatment of chronic cutaneous ulcers of the Community of Madrid. | Procedure or surgery | Control, Intervention |
Primary outcome
Complete healing at 6 months of follow-up
Time frame: 6 months
(yes/no) (complete and sustained epithelialisation for at least 2 weeks).
Time elapsed between start of the study and complete healing of the wound
Time frame: 6 months
(in days)
29 secondary outcomes
Degree of healing (Resvech 2.0)
Time frame: Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
Ulceral area
Time frame: Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
Health-related quality of life for patients with venous ulcers (CCVUQ-e)
Time frame: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Perceived pain: visual analogical scale of the McGill questionnaire
Time frame: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Level of adherence to the intervention "Active Legs". Number of steps.
Time frame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Level of adherence to the intervention "Active Legs". Time.
Time frame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Level of adherence to the intervention "Active Legs". The self-reported information by the patient of the domiciliary exercise program.
Time frame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Age (sociodemographic variables)
Time frame: Measured at the beginning (baseline)
Sex (sociodemographic variables)
Time frame: Measured at the beginning (baseline)
Living alone (sociodemographic variables)
Time frame: Measured at the beginning (baseline)
Employment status (sociodemographic variables)
Time frame: Measured at the beginning (baseline)
Education level (sociodemographic variables)
Time frame: Measured at the beginning (baseline)
Weight (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
Height (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
Underlying disease (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
ABI (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
Tobacco consumption (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
Alcohol consumption (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
Topical and systemic treatment (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
Adherence to multilayer compression therapy (variables related to the healing process)
Time frame: Measured at the beginning (basal) and fortnightly until 3 months and at 6 months .
Physical activity level measured by the Minnesota free time physical activity questionnaire (variables related to the healing process)
Time frame: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Type of daily walking (variables related to the healing process)
Time frame: Measured at the beginning (baseline)
Location of the ulcer (prognostic variables)
Time frame: Measured at the beginning (baseline)
Number of ulcers at the time of the study (prognostic variables)
Time frame: Measured at the beginning (baseline)
Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)
Time frame: Measured at the beginning (baseline)
Recurrent ulcer (prognostic variables)
Time frame: Measured at the beginning (baseline)
Recurrence (variables related to recurrences)
Time frame: measured at 6 months of follow-up
Use of compression stockings (variables related to recurrences)
Time frame: measured at 6 months of follow-up
Hydration of the legs (variables related to recurrences)
Time frame: measured at 6 months of follow-up
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 20 Mar 2024.
- Derived from this study: PubMed 41372918Herraiz-Ahijado B, Folguera-Alvarez C, Rodriguez-Barrientos R, Sanchez-Ruano R, Pascual-Garcia M, Mori-Vara P, Verdu-Soriano J, Rico-Blazquez M; Active Legs Group. Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: active legs RCT. BMC Nurs. 2025 Dec 10;25(1):38. doi: 10.1186/s12912-025-04189-0.
- Derived from this study: PubMed 36899351Herraiz-Ahijado B, Folguera-Alvarez C, Verdu-Soriano J, Mori-Vara P, Rico-Blazquez M. Active legs: Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: a RCT protocol study. BMC Nurs. 2023 Mar 10;22(1):65. doi: 10.1186/s12912-023-01214-y.
- 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.
Borja Jesús Herraiz Ahijado, Nurse principal investigator
Gerencia Asistencial de Atención Primaria de la Comunidad de 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 Project active legs in people with Varicose Ulcer, 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 9 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 20 Mar 2024. 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?
Complete healing at 6 months of follow-up (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04039789, which also lists 2 linked publications.
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 20 Mar 2024.