LipedemaNCT07294014
Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema
An observational study of Lipedema and Hypermobility Syndrome (Disorder), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a chronic adipose tissue disorder that commonly leads to joint laxity, hypermobility, and functional limitations, yet its impact on foot morphology has not been systematically examined. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema, Hypermobility Syndrome (Disorder), Pes Planus
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Apr 2026
- Phase
- Observational
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients presenting to the Physical Medicine and Rehabilitation outpatient clinics at Marmara University Pendik Training and Research Hospital will be screened for eligibility. The study population will include women clinically diagnosed with lipedema according to established diagnostic criteria, as well as age- and BMI-matched female patients with nonspecific foot pain who will serve as the control group.
Who may be able to join
None listed.
Who cannot join
- Pregnancy
- Illiteracy
- Inability or unwillingness to provide written and verbal informed consent
- History of lower extremity fracture, trauma, or orthopedic surgery
- Diagnosis of diabetes mellitus
- Known rheumatologic disease
- Known polyneuropathy or peripheral nerve injury affecting the lower extremities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul
Gökçenur Yalçın, +90 216 625 45 45, gokce_cihaner@hotmail.com
About this study
Official title: Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema: A Cross-Sectional Study
Lipedema is a chronic adipose tissue disorder that commonly leads to joint laxity, hypermobility, and functional limitations, yet its impact on foot morphology has not been systematically examined. This case-control study aims to investigate whether patients with lipedema exhibit a higher prevalence of generalized joint hypermobility and foot structural abnormalities-specifically pes planus-compared with age- and BMI-matched controls. Using radiographic measurements (Meary angle and calcaneal inclination angle), clinical hypermobility assessment, and validated functional scales, the study seeks to determine the relationship between lipedema, hypermobility, and foot function.
Read the detailed description
Lipedema is a progressive adipose tissue disorder characterized by disproportionate subcutaneous fat accumulation, predominantly in the lower extremities. Patients frequently experience pain, easy bruising, reduced quality of life, and musculoskeletal complications such as joint laxity and hypermobility. Although previous studies have suggested an increased prevalence of hypermobility in individuals with lipedema, the potential impact of these biomechanical changes on foot posture and foot function remains insufficiently studied.
This case-control, single-session, single-blind (participant-blinded) study is designed to evaluate structural and functional foot characteristics in women diagnosed with lipedema, compared with age- and BMI-matched controls presenting with nonspecific foot pain. The primary radiographic variables include the Meary angle and calcaneal inclination angle measured on standardized lateral foot radiographs. These measurements provide objective quantification of midfoot alignment and arch height, enabling detection of pes planus and related morphological deviations.
In addition to radiographic assessment, the study incorporates established clinical tools to quantify joint hypermobility, foot function, pain severity, and physical activity levels. The Beighton score will be used to determine generalized joint hypermobility. Functional and symptomatic status will be evaluated using validated questionnaires, including the Foot Function Index (FFI), Lower Extremity Functional Scale (LEFS), Visual Analog Scale (VAS) for pain, and the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Sociodemographic and clinical data-including disease duration, comorbidities, and lower extremity volumetric measurements-will be systematically recorded to identify potential associations between patient characteristics and foot morphology. The study aims to clarify whether the presence of hypermobility in lipedema contributes to alterations in medial longitudinal arch structure and whether these changes are more prevalent than in a matched control population.
The findings are expected to provide insight into the biomechanical consequences of lipedema, support more accurate clinical assessment, and potentially guide rehabilitative strategies targeting lower extremity alignment and function in this patient group.
- Keywords
- lipedema, mypermobility, foot function, pes planus, joint hyper mobility, foot morphology, Meary angle, calcaneal inclination angle
- Medical subject headings
- Lipedema, Flatfoot, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lipedema group | Participants diagnosed with lipedema based on established clinical criteria, including characteristic bilateral lower-extremity adipose tissue enlargement, pain or tenderness on palpation, easy bruising, and preservation of foot anatomy. Diagnosis is confirmed by a physiatrist or relevant specialist through medical history and physical examination. These participants will undergo radiographic foot assessment, hypermobility evaluation, and functional testing as part of the study protocol. | |
| Control group | Age- and BMI-matched female participants presenting with nonspecific foot pain but without a diagnosis or clinical suspicion of lipedema, lymphedema, connective tissue disorders, or systemic inflammatory disease. These individuals will undergo the same radiographic, hypermobility, and functional assessments as the lipedema group, allowing for direct comparison of foot morphology and joint mobility parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meary angle (Degrees)
The Meary angle (talo-first metatarsal angle) will be measured on standardized lateral foot radiographs to evaluate medial longitudinal arch alignment. Increased angles indicate midfoot collapse and are used to identify pes planus. Higher values represent greater deviation from normal alignment.
Measured: Day 1
Calcaneal Inclination Angle (Degrees)
The calcaneal inclination angle will be measured on lateral foot radiographs to assess arch height. Lower angles indicate reduced arch height, consistent with pes planus. Measurements are obtained using established radiographic guidelines.
Measured: Day 1
Secondary outcomes (5)
Beighton Score (0-9)
Generalized joint hypermobility will be evaluated using the Beighton Score, a validated 9-point scale assessing joint laxity in the fingers, elbows, knees, and spine. A score ≥4 indicates generalized hypermobility.
Measured: Day 1
Lower Extremity Functional Scale (LEFS) Score
The LEFS questionnaire assesses lower-extremity functional status across daily activities. Scores range from 0 to 80, with higher scores indicating better function.
Measured: Day 1
Foot Function Index (FFI) Total Score
The FFI evaluates foot-related disability and pain using 23 items across three subscales: pain, disability, and activity limitation. Higher scores reflect greater functional impairment.
Measured: Day 1
Visual Analog Scale (VAS) for Pain (0-100 mm)
Pain severity in both lower extremities will be assessed in three conditions:
VAS-Movement VAS-Rest VAS-Night Higher values indicate greater pain intensity.
Measured: Day 1
Physical Activity Level (IPAQ-Short Form)
Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form. Results will classify participants into low, moderate, or high activity categories based on metabolic equivalent (MET)-minutes per week.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294014
- Sponsor's protocol ID
- Marmara-FTR-GNY-02
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07294014
- Acronym / sponsor ID
- Marmara-FTR-GNY-02
- Keywords
- lipedema, mypermobility, foot function, pes planus, joint hyper mobility, foot morphology, Meary angle, calcaneal inclination angle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Dec 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.
Lipedema is a chronic adipose tissue disorder that commonly leads to joint laxity, hypermobility, and functional limitations, yet its impact on foot morphology has not been systematically examined. This case-control study aims to investigate whether patients with lipedema exhibit a higher prevalence of generalized joint hypermobility and foot structural abnormalities-specifically pes planus-compared with age- and BMI-matched controls. Using radiographic measurements (Meary angle and calcaneal inclination angle), clinical hypermobility assessment, and validated functional scales, the study seeks to determine the relationship between lipedema, hypermobility, and foot function.
Detailed description
Lipedema is a progressive adipose tissue disorder characterized by disproportionate subcutaneous fat accumulation, predominantly in the lower extremities. Patients frequently experience pain, easy bruising, reduced quality of life, and musculoskeletal complications such as joint laxity and hypermobility. Although previous studies have suggested an increased prevalence of hypermobility in individuals with lipedema, the potential impact of these biomechanical changes on foot posture and foot function remains insufficiently studied.
This case-control, single-session, single-blind (participant-blinded) study is designed to evaluate structural and functional foot characteristics in women diagnosed with lipedema, compared with age- and BMI-matched controls presenting with nonspecific foot pain. The primary radiographic variables include the Meary angle and calcaneal inclination angle measured on standardized lateral foot radiographs. These measurements provide objective quantification of midfoot alignment and arch height, enabling detection of pes planus and related morphological deviations.
In addition to radiographic assessment, the study incorporates established clinical tools to quantify joint hypermobility, foot function, pain severity, and physical activity levels. The Beighton score will be used to determine generalized joint hypermobility. Functional and symptomatic status will be evaluated using validated questionnaires, including the Foot Function Index (FFI), Lower Extremity Functional Scale (LEFS), Visual Analog Scale (VAS) for pain, and the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Sociodemographic and clinical data-including disease duration, comorbidities, and lower extremity volumetric measurements-will be systematically recorded to identify potential associations between patient characteristics and foot morphology. The study aims to clarify whether the presence of hypermobility in lipedema contributes to alterations in medial longitudinal arch structure and whether these changes are more prevalent than in a matched control population.
The findings are expected to provide insight into the biomechanical consequences of lipedema, support more accurate clinical assessment, and potentially guide rehabilitative strategies targeting lower extremity alignment and function in this patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipedema group | – | –Participants diagnosed with lipedema based on established clinical criteria, including characteristic bilateral lower-extremity adipose tissue enlargement, pain or tenderness on palpation, easy bruising, and preservation of foot anatomy. Diagnosis is confirmed by a physiatrist or relevant specialist through medical history and physical examination. These participants will undergo radiographic foot assessment, hypermobility evaluation, and functional testing as part of the study protocol. |
| Control group | – | –Age- and BMI-matched female participants presenting with nonspecific foot pain but without a diagnosis or clinical suspicion of lipedema, lymphedema, connective tissue disorders, or systemic inflammatory disease. These individuals will undergo the same radiographic, hypermobility, and functional assessments as the lipedema group, allowing for direct comparison of foot morphology and joint mobility parameters. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients presenting to the Physical Medicine and Rehabilitation outpatient clinics at Marmara University Pendik Training and Research Hospital will be screened for eligibility. The study population will include women clinically diagnosed with lipedema according to established diagnostic criteria, as well as age- and BMI-matched female patients with nonspecific foot pain who will serve as the control group.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Pregnancy
- Illiteracy
- Inability or unwillingness to provide written and verbal informed consent
- History of lower extremity fracture, trauma, or orthopedic surgery
- Diagnosis of diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Meary angle (Degrees)
Time frame: Day 1
The Meary angle (talo-first metatarsal angle) will be measured on standardized lateral foot radiographs to evaluate medial longitudinal arch alignment. Increased angles indicate midfoot collapse and are used to identify pes planus. Higher values represent greater deviation from normal alignment.
Calcaneal Inclination Angle (Degrees)
Time frame: Day 1
The calcaneal inclination angle will be measured on lateral foot radiographs to assess arch height. Lower angles indicate reduced arch height, consistent with pes planus. Measurements are obtained using established radiographic guidelines.
5 secondary outcomes
Beighton Score (0-9)
Time frame: Day 1
Lower Extremity Functional Scale (LEFS) Score
Time frame: Day 1
Foot Function Index (FFI) Total Score
Time frame: Day 1
Visual Analog Scale (VAS) for Pain (0-100 mm)
Time frame: Day 1
Physical Activity Level (IPAQ-Short Form)
Time frame: Day 1
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 2 Jan 2026.
- Individual participant dataSharing planned: Yes
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Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema and Hypermobility Syndrome (Disorder), run by Marmara University at 1 site in Turkey (Türkiye).
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 0 inclusion and 7 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 2 Jan 2026. 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 Turkey (Türkiye). 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 Gökçenur Yalçın, M.D., PMR Specialist (+90 216 414 05 45, gokce_cihaner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meary angle (Degrees) (time frame: Day 1). 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?
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 2 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.