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Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema

Primary Purpose

Lipedema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diosmiplex
Sponsored by
Primus Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipedema

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Primus Pharmaceuticals

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Vasculera

Arm Description

Vasculera 630 milligrams, two times per day

Outcomes

Primary Outcome Measures

Leg Circumference
Percentage of change of leg circumference at 2 and 12 inches above the malliol bilaterally

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
November 7, 2022
Sponsor
Primus Pharmaceuticals
Collaborators
Northeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT05616962
Brief Title
Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema
Official Title
Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Primus Pharmaceuticals
Collaborators
Northeastern University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
three (3) month open-label case study
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vasculera
Arm Type
Other
Arm Description
Vasculera 630 milligrams, two times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Diosmiplex
Other Intervention Name(s)
Vasculera
Intervention Description
diosmin glycoside in combination with alkaline granules known as alka4-complex
Primary Outcome Measure Information:
Title
Leg Circumference
Description
Percentage of change of leg circumference at 2 and 12 inches above the malliol bilaterally
Time Frame
Baseline to month 3 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Levy, MD
Organizational Affiliation
Primus Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Primus Pharmaceuticals
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema

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