Lipedema Clinical Trial
Official title:
Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
NCT number | NCT05616962 |
Other study ID # | PLP-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 20, 2019 |
Est. completion date | September 23, 2019 |
Verified date | November 2022 |
Source | Primus Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | September 23, 2019 |
Est. primary completion date | September 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Primus Pharmaceuticals | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Primus Pharmaceuticals | Northeastern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leg Circumference | Percentage of change of leg circumference at 2 and 12 inches above the malliol bilaterally | Baseline to month 3 visit |
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