LipedemaNCT06954870
Effect of Systemic and Local Ozone Therapy in Lipedema
A study testing Ozone therapy in people with Lipedema and Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a disease characterized by enlargement of the subcutaneous tissue and is observed only in the female population. Recently, the inflammatory cascade has been suggested to be the initiator of lipoedema and to play a role in its progression. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema, Pain, Activities of Daily Living
- What is being tested?
- Ozone therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 1 Oct 2025
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have been diagnosed with clinical lipedema.
- Pain assessed by VAS of 5 or more
- Being a woman
- Being between 18-65 years old
Who cannot join
- Presence of venous insufficiency leading to subcutaneous changes
- Having diseases that may cause edema
- Use of painkillers (NSAIDs/Opioids) up to 1 week before the injection
- Open wound or infection at the site of infection
- Bleeding disorders or use of anticoagulant, antiplatelet drugs uncontrolled systemic disease
- G6PD deficiency
- Cases where the pain cannot be explained by lipoedematous tissue
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
Ankara, 06200
About this study
Official title: Is Ozone Therapy an Effective Treatment for Lipedema? Comparison of Systemic and Local Ozone Treatments
Lipedema is a disease characterized by enlargement of the subcutaneous tissue and is observed only in the female population. Recently, the inflammatory cascade has been suggested to be the initiator of lipoedema and to play a role in its progression. The presence of pain in the involved areas is the most important symptom affecting the patient's QoL.
In the literature, ozone therapy is used both locally and systemically in many diseases in which inflammation is involved in the etiopathogenesis. There are many studies on plantar fasciitis, lateral epicondylitis, rheumatoid arthritis, osteoarthritis, etc. In addition to its anti-inflammatory properties, ozone therapy, which has analgesic and aseptic properties, has not been found in the literature in patients with lipedema.
The aim of this study was to investigate the effect of ozone therapy on pain symptoms and subcutaneous tissue thickness in patients with lipedema and to compare local and systemic ozone applications in these patients.
Read the detailed description
The study, which is planned as a prospective randomized intervention, will include 50 female patients aged 18-65 years with a diagnosis of lipedema by a physician who applied to Etlik City Hospital Physical Medicine and Rehabilitation clinic and had pain >4 evaluated by VAS.
Since there is no study evaluating ozone therapy in lipedema in the literature, the sample size calculated with G*Power 3.0.10a based on another ozone therapy study was found to be 15 patients each. Considering the possibility of dropout from the study, the sample size was determined as 50 volunteers in total.
After clinical diagnosis, pain with visual analog scale (VAS) and pain detect pain questionnaire will be applied to evaluate neuropathic pain. In patients with lipedema, measurements will be made by a physical medicine and rehabilitation physician with 10 years of experience in musculoskeletal ultrasonography from the areas previously defined ultrasonographically in the literature (Midpoint between the superior anterior iliac crest and the inferior patellar border, medial tubercle of the femur, midpoint between the tibial tuberosity and the medial malleolus, midpoint between the lateral malleolus and the fibular head, medial supramalleolar) with the ultrasonography device available in the clinic.Patients' age, comorbidities, medications and routine laboratory parameters such as neutrophil/lymphocyte ratio, platelet distribution width, mean platelet volume, sedimentation, CRP, hemogram values will be recorded. VAS, pain detection and ultrasonographic measurements will be repeated at the 1st and 3rd month after the end of the application.
After the patients were randomized into three groups, the first group will receive local ozone, the second group will receive systemic ozone, and the third group will receive both local and systemic ozone. Local ozone will be injected into the painful points of the patient at the level of the medial tubercle of the femur, 10 gamma 10 cc ozone injection will be made radiationally from 5 regions with 1 cm intervals under the guidance of USG (3 sessions). Systemic ozone application will be given in 3 sessions of 40 gamma each.
- Conditions
- Lipedema, Pain, Activities of Daily Living, Musculoskeletal Ultrasound
- Being tested
- Ozone therapy
- Medical subject headings
- Lipedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone therapyOther
As detailed in the research arms, major ozone application and local ozone application will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Systemic ozone therapy | Experimental | 1 session of 40 gamma per week, a total of three weeks of major ozone therapy will be applied Receives: Other: Ozone therapy |
| Local ozone therapy | Experimental | 10 gamma local ozone injection per week, a total of three weeks will be performed 5 times with 1 cm intervals to the painful points of the patient. Receives: Other: Ozone therapy |
| Both systemic and local ozone therapy | Experimental | 1 session of 40 gamma per week, a total of three weeks of major ozone therapy will be applied and also 10 gamma local ozone injection per week, a total of three weeks will be performed 5 times with 1 cm intervals to the painful points of the patient. Receives: Other: Ozone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
A visual analog scale will be used to assess pain intensity. In this scale, which is scored between 1-10, 0 indicates the best condition and 10 indicates the most severe pain.
Measured: before application, at 1st and 3rd month
Secondary outcomes (2)
painDETECT Questionnaire
painDETECT Questionnaire will be performed for neuropathic pain. A total score of 19 or more is indicative of likely neuropathic pain.
Measured: before application, at 1st and 3rd month
Subcutaneous ultrasonographic measurement
Subcutaneous ultrasonographic measurement will be performed. The measurement of subcutaneous adipose tissue will be recorded in mm.
Measured: before application, at 1st and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start25 Mar 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Başak Mansız-Kaplan, Ankara Etlik City Hospital
- Investigators
- Başak Mansız Kaplan, MD,AssocProf, Principal investigator, Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954870
- Sponsor's protocol ID
- 2025/16
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Ozone Therapy an Effective Treatment for Lipedema? Comparison of Systemic and Local Ozone Treatments
- ClinicalTrials.gov ID
- NCT06954870
- Acronym / sponsor ID
- 2025/16
- Conditions
- Lipedema, Pain, Activities of Daily Living, Musculoskeletal Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 2 May 2025 (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 disease characterized by enlargement of the subcutaneous tissue and is observed only in the female population. Recently, the inflammatory cascade has been suggested to be the initiator of lipoedema and to play a role in its progression. The presence of pain in the involved areas is the most important symptom affecting the patient's QoL.
In the literature, ozone therapy is used both locally and systemically in many diseases in which inflammation is involved in the etiopathogenesis. There are many studies on plantar fasciitis, lateral epicondylitis, rheumatoid arthritis, osteoarthritis, etc. In addition to its anti-inflammatory properties, ozone therapy, which has analgesic and aseptic properties, has not been found in the literature in patients with lipedema.
The aim of this study was to investigate the effect of ozone therapy on pain symptoms and subcutaneous tissue thickness in patients with lipedema and to compare local and systemic ozone applications in these patients.
Detailed description
The study, which is planned as a prospective randomized intervention, will include 50 female patients aged 18-65 years with a diagnosis of lipedema by a physician who applied to Etlik City Hospital Physical Medicine and Rehabilitation clinic and had pain >4 evaluated by VAS.
Since there is no study evaluating ozone therapy in lipedema in the literature, the sample size calculated with G*Power 3.0.10a based on another ozone therapy study was found to be 15 patients each. Considering the possibility of dropout from the study, the sample size was determined as 50 volunteers in total.
After clinical diagnosis, pain with visual analog scale (VAS) and pain detect pain questionnaire will be applied to evaluate neuropathic pain. In patients with lipedema, measurements will be made by a physical medicine and rehabilitation physician with 10 years of experience in musculoskeletal ultrasonography from the areas previously defined ultrasonographically in the literature (Midpoint between the superior anterior iliac crest and the inferior patellar border, medial tubercle of the femur, midpoint between the tibial tuberosity and the medial malleolus, midpoint between the lateral malleolus and the fibular head, medial supramalleolar) with the ultrasonography device available in the clinic.Patients' age, comorbidities, medications and routine laboratory parameters such as neutrophil/lymphocyte ratio, platelet distribution width, mean platelet volume, sedimentation, CRP, hemogram values will be recorded. VAS, pain detection and ultrasonographic measurements will be repeated at the 1st and 3rd month after the end of the application.
After the patients were randomized into three groups, the first group will receive local ozone, the second group will receive systemic ozone, and the third group will receive both local and systemic ozone. Local ozone will be injected into the painful points of the patient at the level of the medial tubercle of the femur, 10 gamma 10 cc ozone injection will be made radiationally from 5 regions with 1 cm intervals under the guidance of USG (3 sessions). Systemic ozone application will be given in 3 sessions of 40 gamma each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic ozone therapy | Experimental | Other: Ozone therapy1 session of 40 gamma per week, a total of three weeks of major ozone therapy will be applied |
| Local ozone therapy | Experimental | Other: Ozone therapy10 gamma local ozone injection per week, a total of three weeks will be performed 5 times with 1 cm intervals to the painful points of the patient. |
| Both systemic and local ozone therapy | Experimental | Other: Ozone therapy1 session of 40 gamma per week, a total of three weeks of major ozone therapy will be applied and also 10 gamma local ozone injection per week, a total of three weeks will be performed 5 times with 1 cm intervals to the painful points of the patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To have been diagnosed with clinical lipedema.
- Pain assessed by VAS of 5 or more
- Being a woman
- Being between 18-65 years old
Key exclusion criteria (7 listed)
- Presence of venous insufficiency leading to subcutaneous changes
- Having diseases that may cause edema
- Use of painkillers (NSAIDs/Opioids) up to 1 week before the injection
- Open wound or infection at the site of infection
- Bleeding disorders or use of anticoagulant, antiplatelet drugs uncontrolled systemic disease
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 |
|---|---|---|
| Ozone therapyAs detailed in the research arms, major ozone application and local ozone application will be performed. | Other | Both systemic and local ozone therapy, Local ozone therapy, Systemic ozone therapy |
Primary outcome
Visual analog scale
Time frame: before application, at 1st and 3rd month
A visual analog scale will be used to assess pain intensity. In this scale, which is scored between 1-10, 0 indicates the best condition and 10 indicates the most severe pain.
2 secondary outcomes
painDETECT Questionnaire
Time frame: before application, at 1st and 3rd month
Subcutaneous ultrasonographic measurement
Time frame: before application, at 1st and 3rd month
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 31 Mar 2026.
- 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.
Başak Mansız Kaplan, MD,AssocProf principal investigator
Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone therapy in people with Lipedema and Pain, run by Ankara Etlik City Hospital 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 4 inclusion and 7 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 31 Mar 2026. 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?
Visual analog scale (time frame: before application, at 1st and 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.