LipedemaLipeGarNCT06964828
Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
A study testing Flat-knitted compression garment in people with Lipedema, run by Isabel Forner-Cordero, MD, PhD at 1 site in Spain.
Trial summary
The goal of this prospective randomized crossover experimental study is to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing lower-limb volume in lipedema. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Flat-knitted compression garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2024to Jul 2026
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of lipedema: increased lowe-limb volume, disproportion between upper and lower body, and pain.
- Lipedema type III stages 1 or 2.
- Negative pitting sign.
- In maintenance treatment phase with a class II circular-knitted compression garment for at least 6 months.
- Adequate compliance with compression garments (worn during the day, except during personal hygiene and water-related activities).
- Written informed consent to participate.
Who cannot join
- Lipedema with fatty lobulations.
- Body Mass Index (BMI) ≥ 30 kg/m2.
- Waist-to-Height Ratio > 0.53.
- Pregnancy.
- Renal, hepatic, or cardiac insufficiency.
- Thrombosis in the lower extremities.
Show all 10Show fewer
- Infection in the lower extremities.
- Active oncological process.
- Current treatment with corticosteroids and other medications that promote fluid retention.
- Inability to read the Patient Information Form (HIP) and/or provide consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Isabel Forner-Cordero, PhD, +34 96 124 66 05, ceic@iislafe.es
Juan Vazquez-Diez, MD
About this study
Official title: Proof of Concept, Randomized, Controlled, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments (Flat vs Circular Knitted) in the Maintenance Treatment of Patients With Lipedema
The goal of this prospective randomized crossover experimental study is to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing lower-limb volume in lipedema. It will assess the effectiveness of the garments and determine any differences between both types of hosiery currently used in routine clinical practice. Participants will be prescribed either circular or flat-knitted pantyhose and wear them daily for 6 months. After 6 months, they will change the type of garment.
Read the detailed description
Lipedema, described by Allen and Hines in 1940, is a syndrome characterized by painful edema in the lower limbs associated with a frequent occurrence of bruises. It mainly affects women and is usually symmetrical.
The management of patients depends on the stage and the presence of edema. In the maintenance phase, the goal is to prevent edema recurrence to avoid an increase in fat deposition in the lower limbs through the use of compression garments.
Currently, there are no guidelines for prescribing compression garments for patients with lipedema regarding the type of garment, fabric, or compression level. Therefore, the prescription by lymphologists is empirical and based on experience.
This study, the first of its kind, aims to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing the volume of the lower limbs and improving or stabilizing the signs and symptoms of patients with lipedema. The study also aims to determine if there are differences between the two types of garments currently used in routine clinical practice.
In order to provide scientific knowledge to guide these decisions, a prospective randomized crossover experimental study is proposed in patients with lipedema type III, stages 1 and 2, undergoing maintenance treatment with circular compression stockings for a minimum of 6 months. Patients meeting inclusion criteria will be randomized to continue receiving a compression garment with the same circular fabric they were wearing or alternatively switch to a compression garment with flat fabric, both for 6 months.
After 6 months, the study goals will be evaluated, and a simple crossover will be performed, switching to the other type of garment for another 6 months. In other words, patients wearing circular fabric garments will change to flat fabric compression garments and vice versa. At the end of the subsequent 6 months, the study goals will be reassessed once more.
To assess the study goals, we will record several variables related to:
- The effectiveness of circular and flat fabric garments
- Patient satisfaction with the garments
- Compliance with garment use
- Patient complaints about the garments
Therefore, patients will be recieve a follow-up visit at 6 months from the baseline assessment and at 6 months after crossover treatment. Garment usage will be assessed through automated calls every 2 weeks during the whole follow-up period.
- Conditions
- Lipedema
- Being tested
- Flat-knitted compression garment
- Keywords
- Lipedema, Compression garments, Maintenance treatment
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flat-knitted compression garmentDevice
Also called Circular-knitted compression garment
Flat knitted compression garments
| Study group | Role | What they receive |
|---|---|---|
| Circular-knitted compression garments | Active comparator | The patient will continue using a compression garment with the same fabric she was wearing before inclusion (circular knitted pantyhose in class 2) Receives: Device: Flat-knitted compression garment |
| Flat-knitted compression garments | Experimental | The patient will change to a flat-knitted pantyhose in class 2 for 6 months Receives: Device: Flat-knitted compression garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Volume Change (PVC)
The Percentage of Volume Change (PVC) at the 6th and 12th month of treatment is calculated using the following mathematical formula:
PVC = [ (Baseline volume- final volume)/ baseline volume] x 100
Where:
- Baseline is the reference volume at the beginning of the treatment.
- Final Volume is the volume at the end of the treatment period (either at the 6th or 12th month).
This calculation provides the percentage change in volume of the lower limbs over the course of the treatment period compared to the initial volume.
We consider maintenance treatment is successful when the Percentage of Volume Change (PVC) is <10% after 6 or 12 months of treatment, relative to the study's baseline. We define disease progression when the PVC is >10% at 6 or 12 months, relative to the study's baseline.
Measured: at the 6th and 12th month of treatment
Secondary outcomes (7)
Pain intensity
Pain in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Measured: at the 6th and 12th month of treatment
Heaviness
Perceived heaviness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Measured: at the 6th and 12th month of treatment
Numbness
Numbness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Measured: at the 6th and 12th month of treatment
Characteristics of pain
Location and type of sensation.
Measured: at the 6th and 12th month of treatment
Compliance
Number of hours per day and days per week, wearing the compression garments
Measured: at the 6th and 12th months of treatment
Reported Quality of Life
LYMQOL (Lymphedema Quality of Life) questionnaire. Individual item scores range from 0 (least impact in quality of life or QOL) to 4 (maximum impact in QOL). Total scores may be calculated as a mean of all individual answers or as a percentage of the maximum possible score. The last question regarding overall quality of life is measured using the visual analogue scale (VAS) ranging from 0 (worst possible QOL) to 10 (best possible QOL).
Measured: at the 6th and 12th months of treatment
Pressure pain threshold
Pressure pain threshold (PPT) will be assessed at the thigh using an algometer. Units: Newtons (N).
Measured: at baseline, 6th and 12 th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start8 May 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies 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
- Crossover
- Model description
- Patients meeting the inclusion criteria will be randomized to either continue wearing a compression garment with circular fabric or switch to a compression garment with flat fabric, both for 6 months. At 6 months, the study goals will be evaluated, and a simple crossover will occur. Patients will switch to the other type of garment for another 6 months.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabel Forner-Cordero, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Provincial de Castellon, Hospital Arnau de Vilanova
- Responsible party
- Sponsor-investigator, Isabel Forner-Cordero, MD, PhD, Instituto de Investigacion Sanitaria La Fe
- Investigators
- ISABEL FORNER-CORDERO, MD, PhD, Principal investigator, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964828
- Sponsor's protocol ID
- LipeGar
- Acronym
- LipeGar
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michelini S, Chiurazzi P, Marino V, Dell'Orco D, Manara E, Baglivo M, Fiorentino A, Maltese PE, Pinelli M, Herbst KL, Dautaj A, Bertelli M. Aldo-Keto Reductase 1C1 (AKR1C1) as the First Mutated Gene in a Family with Nonsyndromic Primary Lipedema. Int J Mol Sci. 2020 Aug 29;21(17):6264. doi: 10.3390/ijms21176264.
PubMed 32872468Ghods M, Georgiou I, Schmidt J, Kruppa P. Disease progression and comorbidities in lipedema patients: A 10-year retrospective analysis. Dermatol Ther. 2020 Nov;33(6):e14534. doi: 10.1111/dth.14534. Epub 2020 Nov 22.
PubMed 33184945Herbst KL, Mirkovskaya L, Bharhagava A, Chava Y, Te CHT. Lipedema fat and signs and symptoms of illness, increase with advancing stage. Archives of Medicine. 2015; 7(4): 1-8.
Kumar B, Lenert P. Joint Hypermobility Syndrome: Recognizing a Commonly Overlooked Cause of Chronic Pain. Am J Med. 2017 Jun;130(6):640-647. doi: 10.1016/j.amjmed.2017.02.013. Epub 2017 Mar 10.
PubMed 28286166Forner-Cordero I, Muñoz-Langa J, Vázquez-Díez J. Lipedema patients have a high prevalence of joint hypermobility. ISL XXVII WORLD CONGRESS 2019, International Society of Lymphology, Buenos Aires (Argentina), September 23-28, 2019.
WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available.
PubMed 14830102Herbst KL. Rare adipose disorders (RADs) masquerading as obesity. Acta Pharmacol Sin. 2012 Feb;33(2):155-72. doi: 10.1038/aps.2011.153.
PubMed 22301856Schmeller W, Meier-Vollrath I. Das Lipodem: neue Möglichkeiten der Therapie. Schweiz Med Forum. 2007;7:150-155.
Halk AB, Damstra RJ. First Dutch guidelines on lipedema using the international classification of functioning, disability and health. Phlebology. 2017 Apr;32(3):152-159. doi: 10.1177/0268355516639421. Epub 2016 Jul 9.
PubMed 27075680Lontok E, Briggs L, Donlan M, Kin Y, Mosley E, Riley EAU, Stevens M. Lipedema. A giving smarter guide. Milken Institute center for strategic philanthropy. 2017.
Hardy D, Williams A. Best practice guidelines for the management of lipoedema. Br J Community Nurs. 2017 Oct 1;22(Sup10):S44-S48. doi: 10.12968/bjcn.2017.22.Sup10.S44. No abstract available.
PubMed 28961048Dayan E, Kim JN, Smith ML, editors. Lipedema - The disease they call FAT: An overview for clinicians. Boston, MA: Lipedema Simplified Publications, The Friedman Center for Lymphedema Research and Treatment at The Center for Advanced Medicine at Northwell Health in collaboration with Lymphatic Education & Research Network (LE&RN); 2017.
Nemes A, Kormanyos A, Domsik P, Kalapos A, Kemeny L, Szolnoky G. The impact of lower body compression garment on left ventricular rotational mechanics in patients with lipedema-Insights from the three-dimensional speckle tracking echocardiographic MAGYAR-Path Study. Clin Obes. 2020 Oct;10(5):e12380. doi: 10.1111/cob.12380. Epub 2020 Jun 23.
PubMed 32573965Forner-Cordero I, Tortosa-Soriano G, Alabajos-Cea A, Ponce-Garrido AB, Muñoz-Langa J. Effect of compression alone or combined with exercise in patients with lipedema. A pilot study. In: Abstracts of the 42nd European Society of Lymphology Congress. Eur J Lymphol Relat Probl. 2016; 28(74): 70.
Reich-Schupke S, Schmeller W, Brauer WJ, Cornely ME, Faerber G, Ludwig M, Lulay G, Miller A, Rapprich S, Richter DF, Schacht V, Schrader K, Stucker M, Ure C. S1 guidelines: Lipedema. J Dtsch Dermatol Ges. 2017 Jul;15(7):758-767. doi: 10.1111/ddg.13036.
PubMed 28677175
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept, Randomized, Controlled, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments (Flat vs Circular Knitted) in the Maintenance Treatment of Patients With Lipedema
- ClinicalTrials.gov ID
- NCT06964828
- Acronym / sponsor ID
- LipeGar / LipeGar
- Conditions
- Lipedema
- Keywords
- Lipedema, Compression garments, Maintenance treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Isabel Forner-Cordero, MD, PhDUniversity, hospital or other
- Collaborators
- Hospital Provincial de Castellon, Hospital Arnau de Vilanova
- Study start
- 8 May 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 May 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.
The goal of this prospective randomized crossover experimental study is to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing lower-limb volume in lipedema. It will assess the effectiveness of the garments and determine any differences between both types of hosiery currently used in routine clinical practice. Participants will be prescribed either circular or flat-knitted pantyhose and wear them daily for 6 months. After 6 months, they will change the type of garment.
Detailed description
Lipedema, described by Allen and Hines in 1940, is a syndrome characterized by painful edema in the lower limbs associated with a frequent occurrence of bruises. It mainly affects women and is usually symmetrical.
The management of patients depends on the stage and the presence of edema. In the maintenance phase, the goal is to prevent edema recurrence to avoid an increase in fat deposition in the lower limbs through the use of compression garments.
Currently, there are no guidelines for prescribing compression garments for patients with lipedema regarding the type of garment, fabric, or compression level. Therefore, the prescription by lymphologists is empirical and based on experience.
This study, the first of its kind, aims to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing the volume of the lower limbs and improving or stabilizing the signs and symptoms of patients with lipedema. The study also aims to determine if there are differences between the two types of garments currently used in routine clinical practice.
In order to provide scientific knowledge to guide these decisions, a prospective randomized crossover experimental study is proposed in patients with lipedema type III, stages 1 and 2, undergoing maintenance treatment with circular compression stockings for a minimum of 6 months. Patients meeting inclusion criteria will be randomized to continue receiving a compression garment with the same circular fabric they were wearing or alternatively switch to a compression garment with flat fabric, both for 6 months.
After 6 months, the study goals will be evaluated, and a simple crossover will be performed, switching to the other type of garment for another 6 months. In other words, patients wearing circular fabric garments will change to flat fabric compression garments and vice versa. At the end of the subsequent 6 months, the study goals will be reassessed once more.
To assess the study goals, we will record several variables related to:
- The effectiveness of circular and flat fabric garments
- Patient satisfaction with the garments
- Compliance with garment use
- Patient complaints about the garments
Therefore, patients will be recieve a follow-up visit at 6 months from the baseline assessment and at 6 months after crossover treatment. Garment usage will be assessed through automated calls every 2 weeks during the whole follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients meeting the inclusion criteria will be randomized to either continue wearing a compression garment with circular fabric or switch to a compression garment with flat fabric, both for 6 months. At 6 months, the study goals will be evaluated, and a simple crossover will occur. Patients will switch to the other type of garment for another 6 months.
| Arm | Type | Receives |
|---|---|---|
| Circular-knitted compression garments | Active comparator | Device: Flat-knitted compression garmentThe patient will continue using a compression garment with the same fabric she was wearing before inclusion (circular knitted pantyhose in class 2) |
| Flat-knitted compression garments | Experimental | Device: Flat-knitted compression garmentThe patient will change to a flat-knitted pantyhose in class 2 for 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of lipedema: increased lowe-limb volume, disproportion between upper and lower body, and pain.
- Lipedema type III stages 1 or 2.
- Negative pitting sign.
- In maintenance treatment phase with a class II circular-knitted compression garment for at least 6 months.
- Adequate compliance with compression garments (worn during the day, except during personal hygiene and water-related activities).
Key exclusion criteria (10 listed)
- Lipedema with fatty lobulations.
- Body Mass Index (BMI) ≥ 30 kg/m2.
- Waist-to-Height Ratio > 0.53.
- Pregnancy.
- Renal, hepatic, or cardiac insufficiency.
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 |
|---|---|---|
| Flat-knitted compression garmentAlso: Circular-knitted compression garmentFlat knitted compression garments | Device | Circular-knitted compression garments, Flat-knitted compression garments |
Primary outcome
Percentage of Volume Change (PVC)
Time frame: at the 6th and 12th month of treatment
The Percentage of Volume Change (PVC) at the 6th and 12th month of treatment is calculated using the following mathematical formula: PVC = [ (Baseline volume- final volume)/ baseline volume] x 100 Where: * Baseline is the reference volume at the beginning of the treatment. * Final Volume is the volume at the end of the treatment period (either at the 6th or 12th month). This calculation provides the percentage change in volume of the lower limbs over the course of the treatment period compared to the initial volume. We consider maintenance treatment is successful when the Percentage of Volume Change (PVC) is <10% after 6 or 12 months of treatment, relative to the study's baseline. We define disease progression when the PVC is >10% at 6 or 12 months, relative to the study's baseline.
7 secondary outcomes
Pain intensity
Time frame: at the 6th and 12th month of treatment
Heaviness
Time frame: at the 6th and 12th month of treatment
Numbness
Time frame: at the 6th and 12th month of treatment
Characteristics of pain
Time frame: at the 6th and 12th month of treatment
Compliance
Time frame: at the 6th and 12th months of treatment
Reported Quality of Life
Time frame: at the 6th and 12th months of treatment
Pressure pain threshold
Time frame: at baseline, 6th and 12 th months.
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 14 May 2025.
- Background: PubMed 32872468Michelini S, Chiurazzi P, Marino V, Dell'Orco D, Manara E, Baglivo M, Fiorentino A, Maltese PE, Pinelli M, Herbst KL, Dautaj A, Bertelli M. Aldo-Keto Reductase 1C1 (AKR1C1) as the First Mutated Gene in a Family with Nonsyndromic Primary Lipedema. Int J Mol Sci. 2020 Aug 29;21(17):6264. doi: 10.3390/ijms21176264.
- Background: PubMed 33184945Ghods M, Georgiou I, Schmidt J, Kruppa P. Disease progression and comorbidities in lipedema patients: A 10-year retrospective analysis. Dermatol Ther. 2020 Nov;33(6):e14534. doi: 10.1111/dth.14534. Epub 2020 Nov 22.
- BackgroundHerbst KL, Mirkovskaya L, Bharhagava A, Chava Y, Te CHT. Lipedema fat and signs and symptoms of illness, increase with advancing stage. Archives of Medicine. 2015; 7(4): 1-8.
- Background: PubMed 28286166Kumar B, Lenert P. Joint Hypermobility Syndrome: Recognizing a Commonly Overlooked Cause of Chronic Pain. Am J Med. 2017 Jun;130(6):640-647. doi: 10.1016/j.amjmed.2017.02.013. Epub 2017 Mar 10.
- BackgroundForner-Cordero I, Muñoz-Langa J, Vázquez-Díez J. Lipedema patients have a high prevalence of joint hypermobility. ISL XXVII WORLD CONGRESS 2019, International Society of Lymphology, Buenos Aires (Argentina), September 23-28, 2019.
- Background: PubMed 14830102WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available.
- Background: PubMed 22301856Herbst KL. Rare adipose disorders (RADs) masquerading as obesity. Acta Pharmacol Sin. 2012 Feb;33(2):155-72. doi: 10.1038/aps.2011.153.
- BackgroundSchmeller W, Meier-Vollrath I. Das Lipodem: neue Möglichkeiten der Therapie. Schweiz Med Forum. 2007;7:150-155.
- Background: PubMed 27075680Halk AB, Damstra RJ. First Dutch guidelines on lipedema using the international classification of functioning, disability and health. Phlebology. 2017 Apr;32(3):152-159. doi: 10.1177/0268355516639421. Epub 2016 Jul 9.
- BackgroundLontok E, Briggs L, Donlan M, Kin Y, Mosley E, Riley EAU, Stevens M. Lipedema. A giving smarter guide. Milken Institute center for strategic philanthropy. 2017.
- Background: PubMed 28961048Hardy D, Williams A. Best practice guidelines for the management of lipoedema. Br J Community Nurs. 2017 Oct 1;22(Sup10):S44-S48. doi: 10.12968/bjcn.2017.22.Sup10.S44. No abstract available.
- BackgroundDayan E, Kim JN, Smith ML, editors. Lipedema - The disease they call FAT: An overview for clinicians. Boston, MA: Lipedema Simplified Publications, The Friedman Center for Lymphedema Research and Treatment at The Center for Advanced Medicine at Northwell Health in collaboration with Lymphatic Education & Research Network (LE&RN); 2017.
- 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.
ISABEL FORNER-CORDERO, MD, PhD principal investigator
Hospital Universitario La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flat-knitted compression garment in people with Lipedema, run by Isabel Forner-Cordero, MD, PhD 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 6 inclusion and 10 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 14 May 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 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?
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 ISABEL FORNER-CORDERO, MD, PhD (+34649179852, ifornercordero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Volume Change (PVC) (time frame: at the 6th and 12th month of treatment). 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 NCT06964828, which also lists 26 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 14 May 2025.