LipedemaNCT04492046
Complex Decongestive Applications in Patients With Lipedema
An observational study of Lipedema, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a rare condition which almost exclusively affects women. The disease is characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is often mistaken for simple obesity. In most patients, the hips, buttocks, thighs, knees, and lower legs are affected. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lipedema
- What is being tested?
- Manual Lymph Drainage and Bandaging
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2019to 12 Feb 2020
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients included in this study consisted of those who had a diagnosis of lipedema in the lower extremities, between the ages of 18-65.
Who may be able to join
- Being willing to participate in the study
- Being 18-65 years old
- Having a diagnosis of lower extremity lipedema
Who cannot join
- Having edematous disease in the lower extremity such as lymphedema or chronic venous insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Complex Decongestive Applications on Lower Extremity Limb Volume in Patients With Lipedema
Lipedema is a rare condition which almost exclusively affects women. The disease is characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is often mistaken for simple obesity. In most patients, the hips, buttocks, thighs, knees, and lower legs are affected. Upper extremity involvement has been reported to be present in 80% patients. The hands and feet are never affected. The accumulation of subcutaneous fat and edema results in tenderness, sensitivity to touch and pressure and also pain. Patients also tend to bruise easily even after a minimal trauma. It has been reported that the complaint of pain increases with aging.There is no known cure for lipedema. However, conservative treatment with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy is used worldwide as a standard treatment regimen . The aim of this study is to investigate the effect of complex decongestive applications on lower extremity limb circumference and volume in patients with lipedema.
Read the detailed description
All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy Each patient received;
- 45 minutes of manual lymph drainage on both lower extremities,
- Moisturisation of the lower extremities,
- Bandage application
Alongside this routine, the patients were advised to exercise (walk) regularly every day.
This treatment routine was continued until the patients were discharged from the clinic.
- Conditions
- Lipedema
- Being tested
- Manual Lymph Drainage, Bandaging
- Keywords
- Lipedema, Manual lymph drainage, Complex Decongestive Physiotherapy
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymph DrainageOther
Manual lymph drainage is an effective therapeutic method used in the conservative treatment of lipedema. The application was performed on both lower extremities for 45 minutes.
BandagingOther
Multilayered compression bandaging techniques have an assisting role in the further reduction of the volume of the limb and enhance the continuous pump mechanism via the active involvement of muscle pumps. All patients received bandages following Manual lymph drainage application.
| Study group | Role | What they receive |
|---|---|---|
| Complex Decongestive physiotherapy | All participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy. Receives: Other: Manual Lymph Drainage; Other: Bandaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Volume
In measurement of limb volume, the perometer was used. The device measures limb volume via infrared light and it has been reported to be a quick and reliable method. The device has a square frame which is used to surround the perimeter of the limb. The limb interrupts the emitted infrared beams that would normally be sensed by the light-sensing diodes in the two planes. Thus two perpendicular diameter measurements of the limb for the measured segment are provided. The device estimates the opposite two sides based on an elliptical cross-section.
Measured: Change from Baseline limb volume at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start2 Sep 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Yazici, Gazi University
- Investigators
- Gokhan Yazici, PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492046
- Sponsor's protocol ID
- Lipedema
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Volkan-Yazici M, Yazici G, Esmer M. The Effects of Complex Decongestive Physiotherapy Applications on Lower Extremity Circumference and Volume in Patients with Lipedema. Lymphat Res Biol. 2021 Feb;19(1):111-114. doi: 10.1089/lrb.2020.0080. Epub 2020 Oct 30.
PubMed 33124947
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Complex Decongestive Applications on Lower Extremity Limb Volume in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT04492046
- Acronym / sponsor ID
- Lipedema
- Conditions
- Lipedema
- Keywords
- Lipedema, Manual lymph drainage, Complex Decongestive Physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lipedema is a rare condition which almost exclusively affects women. The disease is characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is often mistaken for simple obesity. In most patients, the hips, buttocks, thighs, knees, and lower legs are affected. Upper extremity involvement has been reported to be present in 80% patients. The hands and feet are never affected. The accumulation of subcutaneous fat and edema results in tenderness, sensitivity to touch and pressure and also pain. Patients also tend to bruise easily even after a minimal trauma. It has been reported that the complaint of pain increases with aging.There is no known cure for lipedema. However, conservative treatment with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy is used worldwide as a standard treatment regimen . The aim of this study is to investigate the effect of complex decongestive applications on lower extremity limb circumference and volume in patients with lipedema.
Detailed description
All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy Each patient received;
- 45 minutes of manual lymph drainage on both lower extremities,
- Moisturisation of the lower extremities,
- Bandage application
Alongside this routine, the patients were advised to exercise (walk) regularly every day.
This treatment routine was continued until the patients were discharged from the clinic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex Decongestive physiotherapy | – | Other: Manual Lymph Drainage, Other: BandagingAll participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients included in this study consisted of those who had a diagnosis of lipedema in the lower extremities, between the ages of 18-65.
Key inclusion criteria (3 listed)
- Being willing to participate in the study
- Being 18-65 years old
- Having a diagnosis of lower extremity lipedema
Key exclusion criteria (1 listed)
- Having edematous disease in the lower extremity such as lymphedema or chronic venous insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymph DrainageManual lymph drainage is an effective therapeutic method used in the conservative treatment of lipedema. The application was performed on both lower extremities for 45 minutes. | Other | Complex Decongestive physiotherapy |
| BandagingMultilayered compression bandaging techniques have an assisting role in the further reduction of the volume of the limb and enhance the continuous pump mechanism via the active involvement of muscle pumps. All patients received bandages following Manual lymph drainage application. | Other | Complex Decongestive physiotherapy |
Primary outcome
Limb Volume
Time frame: Change from Baseline limb volume at 6 weeks
In measurement of limb volume, the perometer was used. The device measures limb volume via infrared light and it has been reported to be a quick and reliable method. The device has a square frame which is used to surround the perimeter of the limb. The limb interrupts the emitted infrared beams that would normally be sensed by the light-sensing diodes in the two planes. Thus two perpendicular diameter measurements of the limb for the measured segment are provided. The device estimates the opposite two sides based on an elliptical cross-section.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Derived from this study: PubMed 33124947Volkan-Yazici M, Yazici G, Esmer M. The Effects of Complex Decongestive Physiotherapy Applications on Lower Extremity Circumference and Volume in Patients with Lipedema. Lymphat Res Biol. 2021 Feb;19(1):111-114. doi: 10.1089/lrb.2020.0080. Epub 2020 Oct 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokhan Yazici, PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Volume (time frame: Change from Baseline limb volume at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.