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OpenTrials
Completed

NCT Number: NCT05616962

Vasculera in Participants With Lipedema

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primus Pharmaceuticals

Scottsdale, Arizona, 85251, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diosmiplex

Dietary Supplement

diosmin glycoside in combination with alkaline granules known as alka4-complex

Other names: Vasculera

Primary outcomes

  1. Change in Weight From Baseline

    Time frame: Visit 4 (3 months)

    Weight in kilograms on digital, calibrated bathroom scale

Secondary outcomes

  1. Percentage Change Right Leg at 2 Inches

    Time frame: Visit 4 (3 month)

    Right leg circumference measured at 2 inches above the right lateral malleoli

  2. Change in BMI From Baseline

    Time frame: Visit 4 (3 months)

    BMI in kilograms per meter squared

  3. Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline

    Time frame: 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

  4. Change in Right Leg Discomfort From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  5. Change in Left Leg Discomfort From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  6. Change in Right Leg Feeling of Swelling or Tightness From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  7. Change in Left Leg Feeling of Swelling or Tightness From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  8. Change in Right Leg Tenderness From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  9. Change in Left Leg Tenderness From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  10. Change in Right Leg Bruising From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  11. Change in Left Leg Bruising From Baseline

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  12. Change in Right Leg Redness

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  13. Change in Left Leg Redness

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt

  14. Change in Fatigue

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt

  15. Change in Ability to Perform Activities of Daily Living

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt

  16. Change in the Overall Sense of Wellbeing

    Time frame: Visit 4 (3 months)

    An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt

  17. Investigator Assessment of Response to Therapy

    Time frame: Visit 4 (3 months)

    Likert scale from 0 to 5 where 0 is no response and 5 is the best response

  18. Percentage Change Right Leg at 12 Inches

    Time frame: Visit 4 (3 month)

    Right leg circumference measured at 12 inches above the right lateral malleoli

  19. Percentage Change Left Leg at 2 Inches

    Time frame: Visit 4 (3 month)

    Left leg circumference measured at 2 inches above the left lateral malleoli

  20. Percentage Change Left Leg at 12 Inches

    Time frame: Visit 4 (3 month)

    Left leg circumference measured at 12 inches above the left lateral malleoli

Sponsors and collaborators

Lead sponsor

Primus Pharmaceuticals

Industry

Collaborators

  • Northeastern University

Registry information

Official study title

Vasculera in Participants With Lipedema an Exploratory Controlled Case Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2022
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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