- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616962
Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema
November 7, 2022 updated by: Primus Pharmaceuticals
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 patients 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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Scottsdale, Arizona, United States, 85251
- Primus Pharmaceuticals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Vasculera
Vasculera 630 milligrams, two times per day
|
diosmin glycoside in combination with alkaline granules known as alka4-complex
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leg Circumference
Time Frame: Baseline to month 3 visit
|
Percentage of change of leg circumference at 2 and 12 inches above the malliol bilaterally
|
Baseline to month 3 visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Robert Levy, MD, Primus Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2019
Primary Completion (Actual)
September 23, 2019
Study Completion (Actual)
September 23, 2019
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 15, 2022
Study Record Updates
Last Update Posted (Actual)
November 15, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Article written by investigator Response to all queries
IPD Sharing Time Frame
120 days from NCT assignment
IPD Sharing Access Criteria
Access will be given when requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Yuksek Ihtisas UniversityCompleted
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