Vasculera in Participants With Lipedema

Not Applicable

Completed

Conditions: Lipedema

Interventions: Dietary Supplement: Diosmiplex

Registration Number: NCT05616962

Lead Sponsor: Primus Pharmaceuticals

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vasculera	Diosmiplex	Vasculera 630 milligrams, two times per day

Primary Outcome Measures

Name	Time	Method
Change in Weight From Baseline	Visit 4 (3 months)	Weight in kilograms on digital, calibrated bathroom scale

Secondary Outcome Measures

Name	Time	Method
Investigator Assessment of Response to Therapy	Visit 4 (3 months)	Likert scale from 0 to 5 where 0 is no response and 5 is the best response
Percentage Change Right Leg at 2 Inches	Visit 4 (3 month)	Right leg circumference measured at 2 inches above the right lateral malleoli
Percentage Change Right Leg at 12 Inches	Visit 4 (3 month)	Right leg circumference measured at 12 inches above the right lateral malleoli
Change in BMI From Baseline	Visit 4 (3 months)	BMI in kilograms per meter squared
Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline	Visit 4 (3 months)	Short Western Ontario and McMaster Universities Osteoarthritis Index total score results calculated by summing the response to individual questions with range from 0 - 96 where 0 is the best score and 96 is the worst
Change in Right Leg Discomfort From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Left Leg Discomfort From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Right Leg Feeling of Swelling or Tightness From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Left Leg Feeling of Swelling or Tightness From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Right Leg Tenderness From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Left Leg Tenderness From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Ability to Perform Activities of Daily Living	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Change in the Overall Sense of Wellbeing	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Change in Right Leg Bruising From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Left Leg Bruising From Baseline	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Right Leg Redness	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Left Leg Redness	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Change in Fatigue	Visit 4 (3 months)	An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Percentage Change Left Leg at 2 Inches	Visit 4 (3 month)	Left leg circumference measured at 2 inches above the left lateral malleoli
Percentage Change Left Leg at 12 Inches	Visit 4 (3 month)	Left leg circumference measured at 12 inches above the left lateral malleoli