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Completed
NCT05616962
Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema
Conditions: Lipedema
Sex: All
Ages: 20 Years – 70 Years
Phase: NA
Enrollment: 34
Sponsor: Primus Pharmaceuticals
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:established diagnosis of lipedema for at least one (1) yearwomen, ages 20 to 70 yearsscore of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well beingbe willing to stop compression therapy for one week prior to each visitExclusion Criteria:other forms of leg enlargement, including lymphedemaany primary systemic vasculopathyhistory of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visitconcomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulabilityconcomitant use of diclofenac, metronidazole or chlorzoxazoneuncontrolled hypertension (BP>170/110), unstable cardiac disease, active skin ulcerationany other disease or condition that, in the opinion of the investigator, might put thesubject at risk by participation in this study OR confound evaluation of response to Vasculerahistory 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.
Source: ClinicalTrials.gov (NCT05616962). StuddyBuddy aggregates publicly available trial information.