LipedemaNCT07667270
Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema
A study testing Anti-inflammatory Diet and Physical Therapy and Standard Diet and Physical Therapy in people with Lipedema, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the effectiveness of standard physical therapy methods (Complex Decongestive Therapy, Pneumatic Compression, and Exercise) combined with two different nutritional approaches (personalized anti-inflammatory diet vs. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Anti-inflammatory Diet and Physical Therapy and Standard Diet and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 15 Dec 2027
- Phase
- Interventional
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18 to 65 years.
- Clinical and physical examination confirming Stage I, II, or III lipedema.
- Body Mass Index (BMI) < 45 kg/m^2.
- Ability to walk without restriction.
Who cannot join
- Presence of active malignancy.
- Decompensated heart failure.
- Significant lower extremity peripheral artery disease.
- Acute deep vein thrombosis or active thromboembolism.
- Pregnancy.
- Significant sensory loss or severe neuropathy in the lower extremities.
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- History of lower extremity liposuction within the last 12 months.
- Active severe infection (e.g., cellulitis).
- Other severe systemic diseases deemed unsafe for the study by researchers.
- Severe non-compliance with the study protocol (e.g., missing >30% of planned sessions) or participant requesting withdrawal.
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
Balikesir University Faculty of Medicine Hospital
Balıkesir, 10145
Nilay Sahin, Prof. Dr., +90 555 233 2535, dincernilay@yahoo.com
Ender Salbas, Assist. Prof. Dr., +90 555 669 8639, endersalbas@balikesir.edu.tr
About this study
Official title: Efficacy of Complex Decongestive Therapy, Exercise, and Nutritional Interventions in Women Diagnosed With Lipedema: A Prospective, Single-Blind, Randomized Controlled Trial
The purpose of this study is to compare the effectiveness of standard physical therapy methods (Complex Decongestive Therapy, Pneumatic Compression, and Exercise) combined with two different nutritional approaches (personalized anti-inflammatory diet vs. standard healthy nutrition education) in women diagnosed with lower extremity lipedema.
Read the detailed description
This single-center, prospective, single-blind, randomized controlled trial will include 75 female participants aged 18-65 with Stage I, II, or III lipedema. Participants will receive either a personalized anti-inflammatory diet or standard nutrition education, alongside a standard 12-week physical therapy protocol. Evaluations will be conducted at baseline, 4th, 8th, and 12th weeks to measure changes in lower extremity circumference/volume, body composition, ultrasonographic tissue characteristics, functional capacity (6MWT), pain severity (VAS), and quality of life.
- Conditions
- Lipedema
- Being tested
- Anti-inflammatory Diet and Physical Therapy, Standard Diet and Physical Therapy
- Keywords
- Lipedema, diet, exercise, Complex Decongestive Therapy, Physical Therapy
- Medical subject headings
- Lipedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory Diet and Physical TherapyOther
A personalized anti-inflammatory diet plan formulated by the clinic, combined with a 12-week standard physical therapy protocol. The physical therapy includes compression garments (CCL2), Manual Lymphatic Drainage (MLD), Intermittent Pneumatic Compression (IPC), and an exercise program.
Standard Diet and Physical TherapyOther
Standard healthy nutrition education, combined with a 12-week standard physical therapy protocol. The physical therapy includes compression garments (CCL2), Manual Lymphatic Drainage (MLD), Intermittent Pneumatic Compression (IPC), and an exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory Diet + Physical Therapy | Experimental | Participants in this arm will receive a personalized anti-inflammatory diet plan formulated by the Physical Medicine and Rehabilitation clinic, in addition to a standard 12-week physical therapy protocol (Complex Decongestive Therapy, Intermittent Pneumatic Compression, and exercise). Receives: Other: Anti-inflammatory Diet and Physical Therapy |
| Standard Diet + Physical Therapy | Active comparator | Participants in this arm will receive standard healthy nutrition education, in addition to a standard 12-week physical therapy protocol (Complex Decongestive Therapy, Intermittent Pneumatic Compression, and exercise). Receives: Other: Standard Diet and Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Circumference
Lower extremity circumferences will be measured in centimeters (cm) using a standardized tape measure at predefined anatomical landmarks, including the foot dorsum, ankle, and at 10-cm intervals proximally below the knee, as well as at the thigh. Change in lower extremity circumference from baseline will be evaluated within and between study groups.
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (15)
Change in Body Weight
Body weight (kg) measured at each assessment visit using standardized equipment. Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Subcutaneous tissue thickness (mm)
Subcutaneous tissue thickness (mm) will be assessed via ultrasound at standardized anatomical landmarks (anterior thigh, inferomedial knee, lateral leg, pre-tibial, medial malleolus, and umbilical region). Both parameters are measured directly in millimeters (mm). Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Dermis thickness (mm)
Dermis thickness (mm) will be assessed via ultrasound at standardized anatomical landmarks (anterior thigh, inferomedial knee, lateral leg, pre-tibial, medial malleolus, and umbilical region). Both parameters are measured directly in millimeters (mm). Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Fibrous Septa Prominence
The prominence of fibrous septa within the subcutaneous tissue will be assessed by ultrasound at predefined lower-extremity anatomical landmarks using a visual scoring system ranging from 0 to 3. Higher scores indicate greater fibrotic septal prominence. Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Subcutaneous Fat Tissue Echogenicity
Subcutaneous fat tissue echogenicity will be assessed by ultrasound at predefined lower-extremity anatomical landmarks using a visual scoring system ranging from 0 to 3. Higher scores indicate greater echogenicity. Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Rectus Femoris Muscle Thickness
Rectus femoris muscle thickness will be measured by ultrasound in millimeters (mm) at a standardized anatomical site. Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Rectus Femoris Muscle Echogenicity
Rectus femoris muscle echogenicity will be assessed by ultrasound at a standardized anatomical site using a visual grading scale from Grade 1 to Grade 3. Higher grades indicate greater muscle echogenicity. Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Abdominal Subcutaneous Adipose Tissue Thickness
Abdominal subcutaneous adipose tissue thickness will be measured by ultrasound in millimeters (mm) at locations 5 cm above and 5 cm below the umbilicus. The mean of these two measurements will be used for analysis. Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Functional Capacity
Assessment of submaximal exercise capacity using the 6-Minute Walk Test (6MWT). The total distance walked in 6 minutes will be recorded in meters (m). A higher score indicates better functional capacity.
Measured: Baseline, Week 6, and Week 12
Change in Pain Severity
Evaluation of leg pain intensity using the Visual Analog Scale (VAS). Scale range: 0 (no pain) to 10 (unbearable pain); lower scores indicate better outcome. Change from baseline will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Patient Benefit Index-Lymphedema (PBI-L) Score
The Patient Benefit Index-Lymphedema (PBI-L) is a patient-reported outcome measure used to assess the perceived benefit of treatment in individuals with lymphedema. It includes 23 items addressing treatment goals and the extent to which these goals have been achieved. Scores range from 0 to 4, with higher scores indicating greater patient-perceived treatment benefit. Change from baseline to the specified follow-up time point will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in LYMQOL-Leg Score
The LYMQOL-Leg is an 18-item, lymphedema-specific quality-of-life questionnaire for patients with lower-limb lymphedema. It assesses the impact of lymphedema across relevant quality-of-life domains. Domain scores range from 1 to 4, with lower scores indicating a better outcome and less lymphedema-related impairment. Change from baseline to the specified follow-up time point will be assessed.
Measured: Baseline, Week 6, and Week 12
Change in SF-12 Physical Component Summary Score
The 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) score assesses physical health status, including physical functioning, role limitations due to physical health, bodily pain, and general health perceptions. Scores range from 0 to 100, with higher scores indicating better physical health status. Change from baseline to the specified follow-up time point will be analyzed.
Measured: Baseline, Week 6, and Week 12
Change in SF-12 Mental Component Summary Score
The SF-12 Mental Component Summary (MCS) score assesses mental health status, including psychological well-being, emotional role functioning, social functioning, and vitality. Scores range from 0 to 100, with higher scores indicating better mental health status. Change from baseline to the specified follow-up time point will be evaluated.
Measured: Baseline, Week 6, and Week 12
Change in Beck Depression Inventory Score
The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with lower scores indicating fewer depressive symptoms. Change from baseline to the specified follow-up time point will be assessed, with a decrease in score indicating improvement.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (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.
- 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
- Participants will be randomly assigned to one of two parallel groups: an experimental group receiving a personalized anti-inflammatory diet and a control group receiving standard nutrition education. Both groups will simultaneously receive a standard physical therapy protocol.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Sahin, Balikesir University
- Investigators
- Nilay Sahin, Prof. Dr., Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667270
- Sponsor's protocol ID
- Lipedema_75T253G
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No