Vasculera in Participants With Lipedema

December 9, 2024 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arizona
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. established diagnosis of lipedema for at least one (1) year
  2. women, ages 20 to 70 years
  3. score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being
  4. be willing to stop compression therapy for one week prior to each visit

Exclusion Criteria:

  1. other forms of leg enlargement, including lymphedema
  2. any primary systemic vasculopathy
  3. history of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visit
  4. concomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulability
  5. concomitant use of diclofenac, metronidazole or chlorzoxazone
  6. uncontrolled hypertension (BP>170/110), unstable cardiac disease, active skin ulceration
  7. any other disease or condition that, in the opinion of the investigator, might put the
  8. subject at risk by participation in this study OR confound evaluation of response to Vasculera
  9. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Vasculera
Vasculera 630 milligrams, two times per day
Dietary supplement: Diosmiplex
diosmin glycoside in combination with alkaline granules known as alka4-complex
Other Names:
  • Vasculera

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Weight From Baseline
Time Frame: Visit 4 (3 months)
Weight in kilograms on digital, calibrated bathroom scale
Visit 4 (3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage Change Right Leg at 2 Inches
Time Frame: Visit 4 (3 month)
Right leg circumference measured at 2 inches above the right lateral malleoli
Visit 4 (3 month)
Change in BMI From Baseline
Time Frame: Visit 4 (3 months)
BMI in kilograms per meter squared
Visit 4 (3 months)
Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline
Time Frame: Visit 4 (3 months)
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
Visit 4 (3 months)
Change in Right Leg Discomfort From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Left Leg Discomfort From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Right Leg Feeling of Swelling or Tightness From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Left Leg Feeling of Swelling or Tightness From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Right Leg Tenderness From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Left Leg Tenderness From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Right Leg Bruising From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Left Leg Bruising From Baseline
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Right Leg Redness
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Left Leg Redness
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Visit 4 (3 months)
Change in Fatigue
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Visit 4 (3 months)
Change in Ability to Perform Activities of Daily Living
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Visit 4 (3 months)
Change in the Overall Sense of Wellbeing
Time Frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Visit 4 (3 months)
Investigator Assessment of Response to Therapy
Time Frame: Visit 4 (3 months)
Likert scale from 0 to 5 where 0 is no response and 5 is the best response
Visit 4 (3 months)
Percentage Change Right Leg at 12 Inches
Time Frame: Visit 4 (3 month)
Right leg circumference measured at 12 inches above the right lateral malleoli
Visit 4 (3 month)
Percentage Change Left Leg at 2 Inches
Time Frame: Visit 4 (3 month)
Left leg circumference measured at 2 inches above the left lateral malleoli
Visit 4 (3 month)
Percentage Change Left Leg at 12 Inches
Time Frame: Visit 4 (3 month)
Left leg circumference measured at 12 inches above the left lateral malleoli
Visit 4 (3 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Primus Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northeastern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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
  • SAP
  • 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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