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

Study Overview
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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 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.

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

Official Title
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Vasculera in Participants With Lipedema an Exploratory Controlled Case Study

Conditions
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Lipedema

Intervention / Treatment
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* Dietary Supplement: Diosmiplex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: three (3) month open-label case study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vasculera<br>Vasculera 630 milligrams, two times per day | Dietary Supplement: Diosmiplex<br>* diosmin glycoside in combination with alkaline granules known as alka4-complex<br>* Other names: Vasculera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg Circumference | Percentage of change of leg circumference at 2 and 12 inches above the malliol bilaterally | Baseline to month 3 visit |