LipedemaNCT05616962
Vasculera in Participants With Lipedema
A study testing Diosmiplex in people with Lipedema, run by Primus Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of Vasculera in participants with lipedema and the possible role of the glycocalyx as a physiological target for Vasculera activity. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Lipedema
- What is being tested?
- Diosmiplex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2019to 23 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established diagnosis of lipedema for at least one (1) year
- women, ages 20 to 70 years
- score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being
- be willing to stop compression therapy for one week prior to each visit
Who cannot join
- other forms of leg enlargement, including lymphedema
- any primary systemic vasculopathy
- history of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visit
- concomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulability
- concomitant use of diclofenac, metronidazole or chlorzoxazone
- uncontrolled hypertension (BP>170/110), unstable cardiac disease, active skin ulceration
Show all 9Show fewer
- any other disease or condition that, in the opinion of the investigator, might put the
- subject at risk by participation in this study OR confound evaluation of response to Vasculera
- history of substance abuse within one (1) year of the screening visit or of current alcohol consumption more than one (1) unit daily. For purposes of this study, a unit of alcohol will be considered to be 12 oz of beer, 6 oz of wine or 1 oz of hard spirits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
This study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of Vasculera in participants with lipedema and the possible role of the glycocalyx as a physiological target for Vasculera activity. It is anticipated that the results of this case study will inform the development of a formal randomized, double-blind, placebo controlled trial.
Read the detailed description
The goal of this type of clinical trial is to compare the measurement of participants legs before treatment and after using the treatment for approximately 3 months in clinic patients 20 to 70 years old with lipedema. The main questions it aims to answer are: does the leg circumference decrease and does the participants' overall wellbeing improve?
Participants will:
- Have physical examinations and measurements at baseline and 3 month visit
- Complete wellbeing self-assessments at baseline and 3 month visit
- Have blood drawn for chemical markers at baseline and 3 month visit
- Complete four visits total
- Conditions
- Lipedema
- Being tested
- Diosmiplex
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiosmiplexDietary supplement
Also called Vasculera
diosmin glycoside in combination with alkaline granules known as alka4-complex
| Study group | Role | What they receive |
|---|---|---|
| Vasculera | Other | Vasculera 630 milligrams, two times per day Receives: Dietary Supplement: Diosmiplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight From Baseline
Weight in kilograms on digital, calibrated bathroom scale
Measured: Visit 4 (3 months)
Secondary outcomes (20)
Percentage Change Right Leg at 2 Inches
Right leg circumference measured at 2 inches above the right lateral malleoli
Measured: Visit 4 (3 month)
Change in BMI From Baseline
BMI in kilograms per meter squared
Measured: Visit 4 (3 months)
Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline
Short Western Ontario and McMaster Universities Osteoarthritis Index total score results calculated by summing the response to individual questions with range from 0 - 96 where 0 is the best score and 96 is the worst
Measured: Visit 4 (3 months)
Change in Right Leg Discomfort From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Left Leg Discomfort From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Right Leg Feeling of Swelling or Tightness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Left Leg Feeling of Swelling or Tightness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Right Leg Tenderness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Left Leg Tenderness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Right Leg Bruising From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Left Leg Bruising From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Right Leg Redness
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Left Leg Redness
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Measured: Visit 4 (3 months)
Change in Fatigue
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Measured: Visit 4 (3 months)
Change in Ability to Perform Activities of Daily Living
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Measured: Visit 4 (3 months)
Change in the Overall Sense of Wellbeing
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Measured: Visit 4 (3 months)
Investigator Assessment of Response to Therapy
Likert scale from 0 to 5 where 0 is no response and 5 is the best response
Measured: Visit 4 (3 months)
Percentage Change Right Leg at 12 Inches
Right leg circumference measured at 12 inches above the right lateral malleoli
Measured: Visit 4 (3 month)
Percentage Change Left Leg at 2 Inches
Left leg circumference measured at 2 inches above the left lateral malleoli
Measured: Visit 4 (3 month)
Percentage Change Left Leg at 12 Inches
Left leg circumference measured at 12 inches above the left lateral malleoli
Measured: Visit 4 (3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start26 May 2019
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- three (3) month open-label case study
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northeastern University
- Responsible party
- Sponsor
- Investigators
- Robert Levy, MD, Study director, Primus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616962
- Sponsor's protocol ID
- PLP-01
- Status last verified
- Jun 2024
- First submitted
- 7 Nov 2022
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Article written by investigator Response to all queries
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
- ClinicalTrials.gov ID
- NCT05616962
- Acronym / sponsor ID
- PLP-01
- Conditions
- Lipedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Northeastern University
- Study start
- 26 May 2019 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of Vasculera in participants with lipedema and the possible role of the glycocalyx as a physiological target for Vasculera activity. It is anticipated that the results of this case study will inform the development of a formal randomized, double-blind, placebo controlled trial.
Detailed description
The goal of this type of clinical trial is to compare the measurement of participants legs before treatment and after using the treatment for approximately 3 months in clinic patients 20 to 70 years old with lipedema. The main questions it aims to answer are: does the leg circumference decrease and does the participants' overall wellbeing improve?
Participants will:
- Have physical examinations and measurements at baseline and 3 month visit
- Complete wellbeing self-assessments at baseline and 3 month visit
- Have blood drawn for chemical markers at baseline and 3 month visit
- Complete four visits total
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- three (3) month open-label case study
| Arm | Type | Receives |
|---|---|---|
| Vasculera | Other | Dietary Supplement: DiosmiplexVasculera 630 milligrams, two times per day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- established diagnosis of lipedema for at least one (1) year
- women, ages 20 to 70 years
- score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being
- be willing to stop compression therapy for one week prior to each visit
Key exclusion criteria (9 listed)
- other forms of leg enlargement, including lymphedema
- any primary systemic vasculopathy
- history of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visit
- concomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulability
- concomitant use of diclofenac, metronidazole or chlorzoxazone
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 |
|---|---|---|
| DiosmiplexAlso: Vasculeradiosmin glycoside in combination with alkaline granules known as alka4-complex | Dietary supplement | Vasculera |
Primary outcome
Change in Weight From Baseline
Time frame: Visit 4 (3 months)
Weight in kilograms on digital, calibrated bathroom scale
20 secondary outcomes
Percentage Change Right Leg at 2 Inches
Time frame: Visit 4 (3 month)
Change in BMI From Baseline
Time frame: Visit 4 (3 months)
Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline
Time frame: Visit 4 (3 months)
Change in Right Leg Discomfort From Baseline
Time frame: Visit 4 (3 months)
Change in Left Leg Discomfort From Baseline
Time frame: Visit 4 (3 months)
Change in Right Leg Feeling of Swelling or Tightness From Baseline
Time frame: Visit 4 (3 months)
Change in Left Leg Feeling of Swelling or Tightness From Baseline
Time frame: Visit 4 (3 months)
Change in Right Leg Tenderness From Baseline
Time frame: Visit 4 (3 months)
Change in Left Leg Tenderness From Baseline
Time frame: Visit 4 (3 months)
Change in Right Leg Bruising From Baseline
Time frame: Visit 4 (3 months)
Change in Left Leg Bruising From Baseline
Time frame: Visit 4 (3 months)
Change in Right Leg Redness
Time frame: Visit 4 (3 months)
Change in Left Leg Redness
Time frame: Visit 4 (3 months)
Change in Fatigue
Time frame: Visit 4 (3 months)
Change in Ability to Perform Activities of Daily Living
Time frame: Visit 4 (3 months)
Change in the Overall Sense of Wellbeing
Time frame: Visit 4 (3 months)
Investigator Assessment of Response to Therapy
Time frame: Visit 4 (3 months)
Percentage Change Right Leg at 12 Inches
Time frame: Visit 4 (3 month)
Percentage Change Left Leg at 2 Inches
Time frame: Visit 4 (3 month)
Percentage Change Left Leg at 12 Inches
Time frame: Visit 4 (3 month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Article written by investigator Response to all queries
Related trials for Lipedema
RecruitingObservational study
Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema
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Effectiveness of Kinesio Taping as an Adjunct to Conservative Treatment in Women With Lipedema
Lipedema
Not yet recruiting
Mind-Body Chair Yoga for Functional Mobility in Individuals With Lipedema
Lipedema
Recruiting
Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema
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Aquatic Versus Land-Based Exercise in Women With Lipedema
Lipedema
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.
Robert Levy, MD study director
Primus Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diosmiplex in people with Lipedema, run by Primus Pharmaceuticals at 1 site in United States.
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 9 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 12 Dec 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Weight From Baseline (time frame: Visit 4 (3 months)). 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 12 Dec 2024.