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Not yet recruiting NCT07667270

Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema

No phase Interventional Lipedema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-inflammatory Diet and Physical Therapy, Standard Diet and Physical Therapy.
Who it may be relevant to
Registry conditions: Lipedema. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Complex Decongestive Therapy, Exercise, and Nutritional Interventions in Women Diagnosed With Lipedema: A Prospective, Single-Blind, Randomized Controlled Trial

Overview

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.

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.

Interventions

  • Other Anti-inflammatory Diet and Physical Therapy
    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.
  • Other Standard Diet and Physical Therapy
    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.

Primary outcome measures

  • Change in Lower Extremity Circumference [Time frame: Baseline, Week 6, and Week 12]
Secondary outcome measures (12)
  • Change in Body Weight [Time frame: Baseline, Week 6, and Week 12]
  • Change in Subcutaneous tissue thickness (mm) [Time frame: Baseline, Week 6, and Week 12]
  • Change in Dermis thickness (mm) [Time frame: Baseline, Week 6, and Week 12]
  • Change in Fibrous Septa Prominence [Time frame: Baseline, Week 6, and Week 12]
  • Change in Subcutaneous Fat Tissue Echogenicity [Time frame: Baseline, Week 6, and Week 12]
  • Change in Rectus Femoris Muscle Thickness [Time frame: Baseline, Week 6, and Week 12]
  • Change in Rectus Femoris Muscle Echogenicity [Time frame: Baseline, Week 6, and Week 12]
  • Change in Abdominal Subcutaneous Adipose Tissue Thickness [Time frame: Baseline, Week 6, and Week 12]
  • Change in Functional Capacity [Time frame: Baseline, Week 6, and Week 12]
  • Change in Pain Severity [Time frame: Baseline, Week 6, and Week 12]
  • Change in Patient Benefit Index-Lymphedema (PBI-L) Score [Time frame: Baseline, Week 6, and Week 12]
  • Change in LYMQOL-Leg Score [Time frame: Baseline, Week 6, and Week 12]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Balikesir University Faculty of Medicine Hospital — Balıkesir

Identifiers

NCT: NCT07667270 · Lipedema_75T253G

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗