Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema
Sponsored by Primus Pharmaceuticals
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 6 years ago
What is this trial about?
What are the participation requirements?
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.