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

NCT07667270 | Not Yet Recruiting

• 1 other identifier: Lipedema_75T253G
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. standard healthy nutrition education) in women diagnosed with lower extremity lipedema.

Conditions

Lipedema

Keywords

Lipedema; diet; exercise; Complex Decongestive Therapy; Physical Therapy

Outcome Measures

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.

  Baseline, Week 6, and Week 12

Secondary Outcomes (15)

• Change in Body Weight

  Baseline, Week 6, and Week 12

• Change in Subcutaneous tissue thickness (mm)

  Baseline, Week 6, and Week 12

• Change in Dermis thickness (mm)

  Baseline, Week 6, and Week 12

• Change in Fibrous Septa Prominence

  Baseline, Week 6, and Week 12

• Change in Subcutaneous Fat Tissue Echogenicity

  Baseline, Week 6, and Week 12

Study Arms (2)

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).

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).

Other: Standard Diet and Physical Therapy

Interventions

Anti-inflammatory Diet and Physical Therapy OTHER

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.

Anti-inflammatory Diet + Physical Therapy

Standard Diet and Physical Therapy OTHER

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.

Standard Diet + Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University Faculty of Medicine Hospital

Balıkesir, 10145, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Nilay Sahin, Prof. Dr.

  Balikesir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilay Sahin, Prof. Dr.

CONTACT

+90 555 233 2535; dincernilay@yahoo.com

Ender Salbas, Assist. Prof. Dr.

CONTACT

+90 555 669 8639; endersalbas@balikesir.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor, who will perform the clinical measurements, ultrasound evaluations, and questionnaires at baseline and all follow-up time points, will be blinded to the group allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: June 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)