Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema
Lipedema
About this trial
This is an interventional treatment trial for Lipedema
Eligibility Criteria
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.
Sites / Locations
- Primus Pharmaceuticals
Arms of the Study
Arm 1
Other
Vasculera
Vasculera 630 milligrams, two times per day