Vasculera in Participants With Lipedema

Primus Pharmaceuticals34 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lipedema

Interventions

DiosmiplexDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Primus Pharmaceuticals

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Change in Weight From Baseline

Weight in kilograms on digital, calibrated bathroom scale

Time frame: Visit 4 (3 months)

Secondary Outcomes

Percentage Change Right Leg at 2 Inches

Right leg circumference measured at 2 inches above the right lateral malleoli

Time frame: Visit 4 (3 month)

Change in BMI From Baseline

BMI in kilograms per meter squared

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Visit 4 (3 months)

Data from ClinicalTrials.gov

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