Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema
ConditionLipedema
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorBalikesir University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, aged 18 to 65 years.
Clinical and physical examination confirming Stage I, II, or III lipedema.
Body Mass Index (BMI) < 45 kg/m².
Ability to walk without restriction.
Disqualifiers
Presence of active malignancy.
Decompensated heart failure.
Significant lower extremity peripheral artery disease.
Acute deep vein thrombosis or active thromboembolism.
Trial design
Design model
Parallel
Treatments tested in this trial
Anti-inflammatory Diet and Physical Therapy
Other interventionA 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 Therapy
Other interventionStandard 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.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Anti-inflammatory Diet + Physical TherapyExperimental treatment 1 intervention
Group B: Standard Diet + Physical TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Week 6, and Week 12Secondary outcomes
1
Change in Body Weight
Body weight (kg) measured at each assessment visit using standardized equipment. Change from baseline will be evaluated.
Time frame
Baseline, Week 6, and Week 122
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.
Time frame
Baseline, Week 6, and Week 123
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.
Time frame
Baseline, Week 6, and Week 124
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.
Time frame
Baseline, Week 6, and Week 12Sponsors and contacts
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Source ClinicalTrials.gov
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