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NCT07667270

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 15 of 15 entries
    • Site details revised
  2. Start date: Jun 15, 2026 to Aug 1, 2026v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Change in Lower Extremity Circumference
Timeframe: Baseline, Week 6, and Week 12

Secondary (15)

Change in Body Weight
Change in Subcutaneous tissue thickness (mm)
Change in Dermis thickness (mm)
Change in Fibrous Septa Prominence
Change in Subcutaneous Fat Tissue Echogenicity
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Change in Rectus Femoris Muscle Thickness
Change in Rectus Femoris Muscle Echogenicity
Change in Abdominal Subcutaneous Adipose Tissue Thickness
Change in Functional Capacity
Change in Pain Severity
Change in Patient Benefit Index-Lymphedema (PBI-L) Score
Change in LYMQOL-Leg Score
Change in SF-12 Physical Component Summary Score
Change in SF-12 Mental Component Summary Score
Change in Beck Depression Inventory Score

Arms and interventions

Anti-inflammatory Diet + Physical TherapyExperimental

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).

Standard Diet + Physical TherapyActive 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).

Other: Anti-inflammatory Diet and Physical Therapy, Standard Diet and Physical Therapy

Sites

1 site in 1 country

  • Balikesir University Faculty of Medicine HospitalBalıkesir, Turkey (Türkiye)