Vasculera in Participants With Lipedema

NCT05616962 | Completed Results

• 1 other identifier: PLP-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (1)

• Change in Weight From Baseline

  Weight in kilograms on digital, calibrated bathroom scale

  Visit 4 (3 months)

Secondary Outcomes (20)

• Percentage Change Right Leg at 2 Inches

  Visit 4 (3 month)

• Change in BMI From Baseline

  Visit 4 (3 months)

• Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline

  Visit 4 (3 months)

• Change in Right Leg Discomfort From Baseline

  Visit 4 (3 months)

• Change in Left Leg Discomfort From Baseline

  Visit 4 (3 months)

Study Arms (1)

Vasculera

OTHER

Vasculera 630 milligrams, two times per day

Dietary Supplement: Diosmiplex

Interventions

Diosmiplex DIETARY_SUPPLEMENT

diosmin glycoside in combination with alkaline granules known as alka4-complex

Also known as: Vasculera

Vasculera

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead
• Northeastern University: collaborator

Study Sites (1)

Primus Pharmaceuticals

Scottsdale, Arizona, 85251, United States

Location

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

For 16 participants, the Change from Baseline could not be calculated as the Baseline measurement was incorrectly measured at 2 centimeters and 12 centimeters above the lateral maleoli and not 2 inches and 12 inches above the lateral maleoli per protocol.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Primus Pharmaceuticals, Inc.

info@primusrx.com

480-483-1410

Study Officials

• Robert Levy, MD

  Primus Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: three (3) month open-label case study

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: May 26, 2019
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 120 days from NCT assignment
• 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.

Locations

US (1)