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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

PLP-01

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
20 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Location

Status