Lower Extremity LymphedemaPhase 4NCT04360889
Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities
A Phase 4 study testing Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin), Tocopherol and Elastic compression in people with Lower Extremity Lymphedema, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
A single-center, open, prospective, randomized, controlled clinical trial will include 120 patients with lower limb lymphedema who undergo treatment in an office-based vascular lab at the Ryazan regional clinical cardiology dispensary, Ryazan, Russia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity Lymphedema
- What is being tested?
- Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin), Tocopherol and Elastic compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2019to 3 Aug 2022
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Secondary lymphedema of the lower extremities
- Signed Informed Consent Form
Who cannot join
- varicose veins of the lower extremities,
- deep vein thrombosis,
- post-thrombotic disease,
- obliterating
- atherosclerosis of the lower limb arteries,
- pregnancy,
Show all 15Show fewer
- lactation,
- cancer,
- acute violation of cerebral circulation in the anamnesis,
- trophic lesions of the skin of the lower extremities,
- diabetes mellitus
- an infectious disease with a history of three months prior to inclusion in the study,
- heart failure,
- kidney failure,
- pulmonary insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
A single-center, open, prospective, randomized, controlled clinical trial will include 120 patients with lower limb lymphedema who undergo treatment in an office-based vascular lab at the Ryazan regional clinical cardiology dispensary, Ryazan, Russia. The patients will be recruited by the staff of the Department of cardiovascular, endovascular, operative surgery, and topographic anatomy, Ryazan state I.P. Pavlov medical university, Russia. The study will include patients who meet the inclusion criteria and do not meet the exclusion criteria. Patients will be divided into 4 groups, 30 subjects each. Group 1-patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day); Group 2-patients with lower limb lymphedema who will receive conservative therapy with Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)-1000mg/day) in addition to elastic compression; Group 3-patients with lower limb lymphedema who will be treated with elastic compression; Group 4- healthy volunteers with no history or clinical signs of venous or lymphatic disease; The duration of this study for each subject will be a maximum of 90 days. Pre-screening and screening will involve 200 subjects with a total of 120 subjects who will be randomized into the study. Peripheral blood samples will be collected to evaluate the activity of biochemical markers of endothelial function; the quality of life will also be assessed.
Read the detailed description
Research methods:
- Physical examination;
- peripheral blood sampling (assessment of the concentration of the markers of endothelial dysfunction, including malondialdehyde (MDA), superoxide dismutase (SD), catalase( CAT), glutathione peroxidase (GP). MDA concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a General MDA assessment kit (manufacturer: USCN Life Science Inc. US-CEA597GE). CAT concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed with a kit for quantitative in vitro assessment of catalase (manufacturer: USCN Life Science Inc. US-SEC418Hu). GP concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a glutathione peroxidase quantification set (abfrontier supplier, Republic of Korea - LF- EK0110). SOD concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed using a total superoxide dismutase detection kit (supplier Cayman Chemical Company, US - 706002).
- Lower limb venous sonography with a linear 5-13 MHz probe;
- Patient questionnaire using a Russian-language version of the Quality of life questionnaire "SF-36 Health Status Survey"
- Conditions
- Lower Extremity Lymphedema
- Being tested
- Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin), Tocopherol, Elastic compression
- Keywords
- endothelial dysfunction, secondary lymphedema of the lower extremities, antioxidants, micronized purified flavonoid fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)Drug
Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) is prescribed at a dose of 1000 mg / day Tocopherol is prescribed at a dose of 400 ME/ day
TocopherolDrug
patients with lower limb lymphedema receiving conservative therapy (elastic compression, to which are added preparations with antioxidant endotheliotropic activity (Tocopherol-400 IU/day)
Elastic compressionOther
patients with lower limb lymphedema receiving conservative therapy that includes only the use of elastic compression
| Study group | Role | What they receive |
|---|---|---|
| Tocopherol | Experimental | patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day) - 90 days Receives: Drug: Tocopherol |
| Micronised purified flavonoid fraction | Experimental | patients with lower limb lymphedema who will receive conservative therapy with Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)-1000mg/day) in addition to elastic compression - 90 days Receives: Drug: Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) |
| Elastic compression | Other | patients with lower limb lymphedema who will be treated with elastic compression - 90 days Receives: Other: Elastic compression |
| Healthy volunteers | No intervention | healthy volunteers with no history or clinical signs of venous or lymphatic disease - 90 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
The malleolar volume of the limb
The circumference at the level of the narrowest part of the lower leg, measured in centimeters
Measured: 90 days
The Level Of Catalase
Biochemical indicator of the functional state of the endothelium. Catalase concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed with a kit for quantitative in vitro assessment of catalase (manufacturer: USCN Life Science Inc. US-SEC418Hu). Unit of measurement ng / ml
Measured: 90 days
The Level Of Superoxide Dismutase
Biochemical indicator of the functional state of the endothelium. Superoxide Dismutase concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed using a total superoxide dismutase detection kit (supplier Cayman Chemical Company, US - 706002). Unit of measurement UI / ml
Measured: 90 days
The Level Of Glutathione Peroxidase
Biochemical indicator of the functional state of the endothelium. Glutathione Peroxidase concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a glutathione peroxidase quantification set (abfrontier supplier, Republic of Korea - LF- EK0110). Unit of measurement ng / ml
Measured: 90 days
The level of Malondialdehyde
Biochemical indicator of the functional state of the endothelium. Malondialdehyde concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a General MDA assessment kit (manufacturer: USCN Life Science Inc. US-CEA597GE). Unit of measurement ng / ml
Measured: 90 days
Quality of life indicators: questionnaire
Patient questionnaire using a Russian-language version of the Quality of life questionnaire "Short Form-36 Health Status Survey". 8 indicators. Indicator from 0 to 100. Higher scores mean a better outcome.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Sep 2019
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity LymphedemaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360889
- Sponsor's protocol ID
- MDA-1
- Status last verified
- Aug 2022
- First submitted
- 18 Apr 2020
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities
- ClinicalTrials.gov ID
- NCT04360889
- Acronym / sponsor ID
- MDA-1
- Conditions
- Lower Extremity Lymphedema
- Keywords
- endothelial dysfunction, secondary lymphedema of the lower extremities, antioxidants, micronized purified flavonoid fraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 24 Apr 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.
A single-center, open, prospective, randomized, controlled clinical trial will include 120 patients with lower limb lymphedema who undergo treatment in an office-based vascular lab at the Ryazan regional clinical cardiology dispensary, Ryazan, Russia. The patients will be recruited by the staff of the Department of cardiovascular, endovascular, operative surgery, and topographic anatomy, Ryazan state I.P. Pavlov medical university, Russia. The study will include patients who meet the inclusion criteria and do not meet the exclusion criteria. Patients will be divided into 4 groups, 30 subjects each. Group 1-patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day); Group 2-patients with lower limb lymphedema who will receive conservative therapy with Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)-1000mg/day) in addition to elastic compression; Group 3-patients with lower limb lymphedema who will be treated with elastic compression; Group 4- healthy volunteers with no history or clinical signs of venous or lymphatic disease; The duration of this study for each subject will be a maximum of 90 days. Pre-screening and screening will involve 200 subjects with a total of 120 subjects who will be randomized into the study. Peripheral blood samples will be collected to evaluate the activity of biochemical markers of endothelial function; the quality of life will also be assessed.
Detailed description
Research methods:
- Physical examination;
- peripheral blood sampling (assessment of the concentration of the markers of endothelial dysfunction, including malondialdehyde (MDA), superoxide dismutase (SD), catalase( CAT), glutathione peroxidase (GP). MDA concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a General MDA assessment kit (manufacturer: USCN Life Science Inc. US-CEA597GE). CAT concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed with a kit for quantitative in vitro assessment of catalase (manufacturer: USCN Life Science Inc. US-SEC418Hu). GP concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a glutathione peroxidase quantification set (abfrontier supplier, Republic of Korea - LF- EK0110). SOD concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed using a total superoxide dismutase detection kit (supplier Cayman Chemical Company, US - 706002).
- Lower limb venous sonography with a linear 5-13 MHz probe;
- Patient questionnaire using a Russian-language version of the Quality of life questionnaire "SF-36 Health Status Survey"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tocopherol | Experimental | Drug: Tocopherolpatients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day) - 90 days |
| Micronised purified flavonoid fraction | Experimental | Drug: Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)patients with lower limb lymphedema who will receive conservative therapy with Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)-1000mg/day) in addition to elastic compression - 90 days |
| Elastic compression | Other | Other: Elastic compressionpatients with lower limb lymphedema who will be treated with elastic compression - 90 days |
| Healthy volunteers | No intervention | –healthy volunteers with no history or clinical signs of venous or lymphatic disease - 90 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Secondary lymphedema of the lower extremities
- Signed Informed Consent Form
Key exclusion criteria (15 listed)
- varicose veins of the lower extremities,
- deep vein thrombosis,
- post-thrombotic disease,
- obliterating
- atherosclerosis of the lower limb arteries,
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 |
|---|---|---|
| Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) is prescribed at a dose of 1000 mg / day Tocopherol is prescribed at a dose of 400 ME/ day | Drug | Micronised purified flavonoid fraction |
| Tocopherolpatients with lower limb lymphedema receiving conservative therapy (elastic compression, to which are added preparations with antioxidant endotheliotropic activity (Tocopherol-400 IU/day) | Drug | Tocopherol |
| Elastic compressionpatients with lower limb lymphedema receiving conservative therapy that includes only the use of elastic compression | Other | Elastic compression |
Primary outcome
The malleolar volume of the limb
Time frame: 90 days
The circumference at the level of the narrowest part of the lower leg, measured in centimeters
The Level Of Catalase
Time frame: 90 days
Biochemical indicator of the functional state of the endothelium. Catalase concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed with a kit for quantitative in vitro assessment of catalase (manufacturer: USCN Life Science Inc. US-SEC418Hu). Unit of measurement ng / ml
The Level Of Superoxide Dismutase
Time frame: 90 days
Biochemical indicator of the functional state of the endothelium. Superoxide Dismutase concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed using a total superoxide dismutase detection kit (supplier Cayman Chemical Company, US - 706002). Unit of measurement UI / ml
The Level Of Glutathione Peroxidase
Time frame: 90 days
Biochemical indicator of the functional state of the endothelium. Glutathione Peroxidase concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a glutathione peroxidase quantification set (abfrontier supplier, Republic of Korea - LF- EK0110). Unit of measurement ng / ml
The level of Malondialdehyde
Time frame: 90 days
Biochemical indicator of the functional state of the endothelium. Malondialdehyde concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a General MDA assessment kit (manufacturer: USCN Life Science Inc. US-CEA597GE). Unit of measurement ng / ml
Quality of life indicators: questionnaire
Time frame: 90 days
Patient questionnaire using a Russian-language version of the Quality of life questionnaire "Short Form-36 Health Status Survey". 8 indicators. Indicator from 0 to 100. Higher scores mean a better outcome.
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 4 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Lower Extremity Lymphedema
Recruiting
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study)
Lymphedema
Recruiting
Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy
RecruitingEarly Phase 1
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
Lower Extremity Lymphedema
Not yet recruiting
Aerobic Exercise Effects in Lower Extremity Lymphedema
Lower Extremity Lymphedema
Recruiting
Boosted Compression for Lower Limb Chronic Edema
Chronic Edema, Lymphedema
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin), Tocopherol and Elastic compression in people with Lower Extremity Lymphedema, run by Ryazan State Medical University at 1 site in Russia.
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 2 inclusion and 15 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 4 Aug 2022. 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 Russia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The malleolar volume of the limb (time frame: 90 days). The study lists 6 primary outcomes in all. 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 4 Aug 2022.