Primus Pharmaceuticals
Scottsdale, Arizona, 85251, United States
NCT Number: NCT05616962
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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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Scottsdale, Arizona, 85251, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
diosmin glycoside in combination with alkaline granules known as alka4-complex
Other names: Vasculera
Time frame: Visit 4 (3 months)
Weight in kilograms on digital, calibrated bathroom scale
Time frame: Visit 4 (3 month)
Right leg circumference measured at 2 inches above the right lateral malleoli
Time frame: Visit 4 (3 months)
BMI in kilograms per meter squared
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
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Time frame: Visit 4 (3 months)
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Time frame: Visit 4 (3 months)
Likert scale from 0 to 5 where 0 is no response and 5 is the best response
Time frame: Visit 4 (3 month)
Right leg circumference measured at 12 inches above the right lateral malleoli
Time frame: Visit 4 (3 month)
Left leg circumference measured at 2 inches above the left lateral malleoli
Time frame: Visit 4 (3 month)
Left leg circumference measured at 12 inches above the left lateral malleoli
Primus Pharmaceuticals
Industry
Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
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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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