Clinical trial NCT05616962: Vasculera in Participants With Lipedema
Official title: Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipedema
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Northeastern University
First posted: 2022-11-15
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: three (3) month open-label case study
Primary purpose: TREATMENT

Brief summary: This study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of Vasculera in participants 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.

Detailed description: The goal of this type of clinical trial is to compare the measurement of participants legs before treatment and after using the treatment for approximately 3 months in clinic patients 20 to 70 years old with lipedema. The main questions it aims to answer are: does the leg circumference decrease and does the participants' overall wellbeing improve?

Participants will:

* Have physical examinations and measurements at baseline and 3 month visit
* Complete wellbeing self-assessments at baseline and 3 month visit
* Have blood drawn for chemical markers at baseline and 3 month visit
* Complete four visits total

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Weight From Baseline
timeFrame: Visit 4 (3 months)
Secondary outcomes:
measure: Percentage Change Right Leg at 2 Inches
timeFrame: Visit 4 (3 month)
measure: Change in BMI From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Right Leg Discomfort From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Left Leg Discomfort From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Right Leg Feeling of Swelling or Tightness From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Left Leg Feeling of Swelling or Tightness From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Right Leg Tenderness From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Left Leg Tenderness From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Right Leg Bruising From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Left Leg Bruising From Baseline
timeFrame: Visit 4 (3 months)
measure: Change in Right Leg Redness
timeFrame: Visit 4 (3 months)
measure: Change in Left Leg Redness
timeFrame: Visit 4 (3 months)
measure: Change in Fatigue
timeFrame: Visit 4 (3 months)
measure: Change in Ability to Perform Activities of Daily Living
timeFrame: Visit 4 (3 months)
measure: Change in the Overall Sense of Wellbeing
timeFrame: Visit 4 (3 months)
measure: Investigator Assessment of Response to Therapy
timeFrame: Visit 4 (3 months)
measure: Percentage Change Right Leg at 12 Inches
timeFrame: Visit 4 (3 month)
measure: Percentage Change Left Leg at 2 Inches
timeFrame: Visit 4 (3 month)
measure: Percentage Change Left Leg at 12 Inches
timeFrame: Visit 4 (3 month)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Primus Pharmaceuticals
state: Arizona
Study officials:
affiliation: Primus Pharmaceuticals
name: Robert Levy, MD
role: STUDY_DIRECTOR
References: