NCT05616962

Vasculera in Participants With Lipedema

Vasculera in Participants With Lipedema an Exploratory Controlled Case Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Primus Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lipedema

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diosmiplex	diosmin glycoside in combination with alkaline granules known as alka4-complex

Timeline

• Start date: 2019-05-26
• Primary completion: 2019-09-23
• Completion: 2019-09-23
• First posted: 2022-11-15
• Last updated: 2024-12-12
• Results posted: 2024-12-12

Locations

1 site across 1 country: United States