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

Lipedema Clinical Trial

Official title:

Vasculera in Participants With Lipedema an Exploratory Controlled Case Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616962
• Other study ID #: PLP-01
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: September 23, 2019

Study information

• Verified date: November 2022
• Source: Primus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lipedema

Intervention

Dietary Supplement:
• Diosmiplex
diosmin glycoside in combination with alkaline granules known as alka4-complex

Locations

Country	Name	City	State
United States	Primus Pharmaceuticals	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Primus Pharmaceuticals	Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg Circumference	Percentage of change of leg circumference at 2 and 12 inches above the malliol bilaterally	Baseline to month 3 visit