An interventional study of Project active legs and Usual care in Varicose Ulcer, sponsored by Gerencia de Atención Primaria, Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Gerencia de Atención Primaria, Madrid · Not applicable, Interventional, and Treatment
Among 12 studies in Varicose Ulcer with a site in Spain — 2 open to participants now, 3 under way, 1 of them phase 3. Varicose Ulcer · Spain.
Among the 12 studies in Varicose Ulcer with a site in Spain, this one is the 10th largest by enrollment, is the only one that started in 2021, is one of 8 with no phase, and was the 6th registered.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
Browse Varicose Ulcer studies →2 of the 12 studies in Varicose Ulcer with a site in Spain are open now. Recruiting first, the newest first:
MediWound Ltd · Sites in Spain, United States, Austria and 6 more countries
Andalusian Network for Design and Translation of Advanced Therapies · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 52 Varicose Ulcer studies recruiting now, 42 (81%) set no upper age limit and 5 (10%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1 · Phase 4 1
First in 2013; this study’s year is marked. 1 started in 2021.
This study's enrollment of 44 is below the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Median enrollment 107 across the 12 interventional studies. Of the 6 that completed or were terminated, 2 (33%) have results posted.
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5 of 12 have an industry lead sponsor. The 10 most frequent:
Gerencia de Atención Primaria, Madrid is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Gerencia de Atención Primaria, Madrid has 2 studies filed under Varicose Ulcer — fewer than ten, so there is no comparison to draw.
1 of the studies in Varicose Ulcer with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568627Phase 3MediWound LtdA Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) | 2026-12 |
Among the 12 studies in Varicose Ulcer with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Usual care
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.
Behavioral: Project active legs · Procedure: Usual care
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)).
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.
Complete healing at 6 months of follow-up
(yes/no) (complete and sustained epithelialisation for at least 2 weeks).
Time frame: 6 months
Time elapsed between start of the study and complete healing of the wound
(in days)
Time frame: 6 months
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.
Time frame: 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.
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)
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.
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
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.
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.
Daily record using the Yamax PZ270 pedometer (15 days memory)
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.
The time in minutes / day
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.
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%.
Time frame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Age (sociodemographic variables)
in years
Time frame: Measured at the beginning (baseline)
Sex (sociodemographic variables)
Male/Female
Time frame: Measured at the beginning (baseline)
Living alone (sociodemographic variables)
Yes/no
Time frame: Measured at the beginning (baseline)
Employment status (sociodemographic variables)
housewife / unemployed / student / worker employee account / worker own account
Time frame: Measured at the beginning (baseline)
Education level (sociodemographic variables)
low / medium / high
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: Measured at the beginning (baseline)
Tobacco consumption (variables related to the healing process)
no smoker / smoker / ex-smoker
Time frame: Measured at the beginning (baseline)
Alcohol consumption (variables related to the healing process)
volume grams of alcohol / week
Time frame: 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.
Time frame: Measured at the beginning (baseline)
Adherence to multilayer compression therapy (variables related to the healing process)
(yes/no)
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)
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 .
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)
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
Time frame: 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
Time frame: Measured at the beginning (baseline)
Number of ulcers at the time of the study (prognostic variables)
in number
Time frame: Measured at the beginning (baseline)
Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)
in days
Time frame: Measured at the beginning (baseline)
Recurrent ulcer (prognostic variables)
(yes/no)
Time frame: Measured at the beginning (baseline)
Recurrence (variables related to recurrences)
(yes / no)
Time frame: measured at 6 months of follow-up
Use of compression stockings (variables related to recurrences)
(Yes/no) for Light / normal / strong compression
Time frame: measured at 6 months of follow-up
Hydration of the legs (variables related to recurrences)
(Yes/no)
Time frame: measured at 6 months of follow-up
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2021 to primary completion in Dec 2021, 6 months.
Of 67 non-industry interventional studies with no phase under Varicose Ulcer, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 65. This study's 6 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Gerencia de Atención Primaria, Madrid