NCT05616962CompletedNot Applicable
Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Primus Pharmaceuticals
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in Weight From Baseline
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •established diagnosis of lipedema for at least one (1) year
- •women, ages 20 to 70 years
- •score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being
- •be willing to stop compression therapy for one week prior to each visit
Exclusion Criteria
- •other forms of leg enlargement, including lymphedema
- •any primary systemic vasculopathy
- •history of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visit
- •concomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulability
- •concomitant use of diclofenac, metronidazole or chlorzoxazone
- •uncontrolled hypertension (BP>170/110), unstable cardiac disease, active skin ulceration
- •any other disease or condition that, in the opinion of the investigator, might put the
- •subject at risk by participation in this study OR confound evaluation of response to Vasculera
- •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.
Arms & Interventions
Vasculera
Other
Vasculera 630 milligrams, two times per day
Intervention: Diosmiplex (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Weight From Baseline
Time Frame: Visit 4 (3 months)
Weight in kilograms on digital, calibrated bathroom scale
Secondary Outcomes
- Percentage Change Right Leg at 2 Inches(Visit 4 (3 month))
- Change in BMI From Baseline(Visit 4 (3 months))
- Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline(Visit 4 (3 months))
- Change in Right Leg Discomfort From Baseline(Visit 4 (3 months))
- Change in Left Leg Discomfort From Baseline(Visit 4 (3 months))
- Change in Right Leg Feeling of Swelling or Tightness From Baseline(Visit 4 (3 months))
- Change in Left Leg Feeling of Swelling or Tightness From Baseline(Visit 4 (3 months))
- Change in Right Leg Tenderness From Baseline(Visit 4 (3 months))
- Change in Left Leg Tenderness From Baseline(Visit 4 (3 months))
- Change in Fatigue(Visit 4 (3 months))
- Change in Ability to Perform Activities of Daily Living(Visit 4 (3 months))
- Change in Right Leg Bruising From Baseline(Visit 4 (3 months))
- Change in Left Leg Bruising From Baseline(Visit 4 (3 months))
- Change in Right Leg Redness(Visit 4 (3 months))
- Change in Left Leg Redness(Visit 4 (3 months))
- Change in the Overall Sense of Wellbeing(Visit 4 (3 months))
- Investigator Assessment of Response to Therapy(Visit 4 (3 months))
- Percentage Change Right Leg at 12 Inches(Visit 4 (3 month))
- Percentage Change Left Leg at 2 Inches(Visit 4 (3 month))
- Percentage Change Left Leg at 12 Inches(Visit 4 (3 month))
Investigators
Study Sites (1)
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BATOLISAipoedema, LipedemaMedDRA version: 21.1Level: PTClassification code: 10063955Term: Lipoedema Class: 100000004861MedDRA version: 20.0Level: LLTClassification code: 10063956Term: Lipedema Class: 10027433CTIS2024-513529-21-00niversite Libre de Bruxelles60