Vasculera in Participants With Lipedema

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: Completed
• Conditions: Lipedema
• Intervention / Treatment: Dietary supplement: Diosmiplex

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

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Primus Pharmaceuticals

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Weight From Baseline	Weight in kilograms on digital, calibrated bathroom scale	Visit 4 (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change Right Leg at 2 Inches	Right leg circumference measured at 2 inches above the right lateral malleoli	Visit 4 (3 month)
Change in BMI From Baseline	BMI in kilograms per meter squared	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	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	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	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	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	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	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	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	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	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	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	Visit 4 (3 months)
Change in Fatigue	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	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	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	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	Right leg circumference measured at 12 inches above the right lateral malleoli	Visit 4 (3 month)
Percentage Change Left Leg at 2 Inches	Left leg circumference measured at 2 inches above the left lateral malleoli	Visit 4 (3 month)
Percentage Change Left Leg at 12 Inches	Left leg circumference measured at 12 inches above the left lateral malleoli	Visit 4 (3 month)

Collaborators and Investigators

• Sponsor: Primus Pharmaceuticals
• Collaborators: Northeastern University
• Investigators: Study Director: Robert Levy, MD, Primus Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 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 (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Lipedema
• 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; 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