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Vasculera in Participants With Lipedema

NCT ID: NCT05616962

Last Updated: 2024-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-26

Study Completion Date

2019-09-23

Brief Summary

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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.

Detailed Description

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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

Conditions

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Lipedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

three (3) month open-label case study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vasculera

Vasculera 630 milligrams, two times per day

Group Type OTHER

Diosmiplex

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Diosmiplex

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vasculera

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northeastern University

OTHER

Sponsor Role collaborator

Primus Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Levy, MD

Role: STUDY_DIRECTOR

Primus Pharmaceuticals

Locations

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Primus Pharmaceuticals

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PLP-01

Identifier Type: -

Identifier Source: org_study_id