NCT05284266

Brief Summary

Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction. Treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking. The Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2022Dec 2027

First Submitted

Initial submission to the registry

March 8, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4.6 years

First QC Date

March 8, 2022

Last Update Submit

September 16, 2025

Conditions

Lipedema

Keywords

LiposuctionConservative treatmentIntermittent pneumatic compressionLipoedemaCompression therapySelf managementDietary management

Outcome Measures

Primary Outcomes (1)

  • Effect of liposuction on lipedema pain

    Assess the effect of liposuction on lipedema pain (Visual Analog Scale (VAS). VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (worst possible pain).

    12 months after the last liposuction surgery

Secondary Outcomes (1)

  • Effect of liposuction on quality of life and everyday activities for patients with lipedema

    12 months after the last liposuction surgery

Other Outcomes (3)

  • Effect of different conservative treatments on lipedema pain and quality of life and everyday activities for patients with lipedema

    6 months after inclusion

  • Adverse effect of liposuction

    12 months after last liposuction surgery

  • Effect of liposuction on the need for conservative treatment

    3 years after last liposuction surgery

Study Arms (4)

Standard conservative treatment

ACTIVE COMPARATOR

Standard conservative treatment consisting of: * Physical therapy, including compression garment and exercise program * Self-care program * Individual counseling from a clinical dietician

Other: Standard conservative treatment

Standard treatment plus additional lymphedema treatment

EXPERIMENTAL

Standard conservative treatment consisting of: * Physical therapy, including compression garment and exercise program * Self-care program * Individual counseling from a clinical dietician Additional lymphedema treatment consisting of intermittent pneumatic compression (IPC)

Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)

Surgical group: Liposuction

EXPERIMENTAL

Early liposuction, 6-9 months after inclusion in study.

Procedure: Liposuction early

Surgical group: Control

ACTIVE COMPARATOR

Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group.

Procedure: Liposuction late

Interventions

Liposuction earlyPROCEDURE

Liposuction 6-9 months after inclusion

Surgical group: Liposuction
Liposuction latePROCEDURE

Liposuction 18-21 months after inclusion

Surgical group: Control
Standard conservative treatmentOTHER

Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program

Standard conservative treatment
Standard conservative treatment with Intermittent Pneumatic Compression (IPC)OTHER

Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)

Standard treatment plus additional lymphedema treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • age 20-65 years
  • significant pain from lipedema
  • lipedema stage 1-2 or localized stage 3

You may not qualify if:

  • Non-fluency in the Norwegian language
  • pregnancy
  • current malignancy
  • previous surgical treatment for lipedema
  • smoking
  • BMI \> 28
  • serious comorbidities such as cardiac-, pulmonary-, renal disease
  • unwillingness to wear compression garments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haraldsplass Deaconess Hospital

Bergen, 5009, Norway

Location

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hildur Skuladottir, PhD

    Haraldsplass Deaconess Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible patients are randomized to two different conservative treatment protocols;either standard conservative treatment (SCT) or standard treatment plus additional lymphedema treatment (intermittent pneumatic compression -IPC). After 6 months the effects of the conservative treatment are evaluated. Patients who still want surgery and fulfill the criteria are randomized (1:1) to early (cases(liposuction initiated 6-9 months after inclusion)) or late surgery (controls (liposuction initiated 18-21 months after inclusion)). Randomization to the surgical group is stratified by conservative treatment arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 17, 2022

Study Start

March 11, 2022

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Data will be available after publication of outcomes.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Data will be available after publication of outcomes.

Locations

NO(1)