N/A N=34 Treatment

Vasculera in Participants With Lipedema

Lipedema

Bottom Line

View on ClinicalTrials.gov: NCT05616962 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Change in Weight From Baseline — 0.340 kilograms — p=0.473

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Diosmiplex (Dietary_supplement)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Primus Pharmaceuticals
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Weight From Baseline	0.340	0.473
SECONDARY Percentage Change Right Leg at 2 Inches	-0.79	0.03199 sig
SECONDARY Change in BMI From Baseline	0.14	0.408
SECONDARY Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline	-7.12	<0.001 sig
SECONDARY Change in Right Leg Discomfort From Baseline	-2.53	<0.001 sig
SECONDARY Change in Left Leg Discomfort From Baseline	-2.62	<0.001 sig
SECONDARY Change in Right Leg Feeling of Swelling or Tightness From Baseline	-2.65	<0.001 sig
SECONDARY Change in Left Leg Feeling of Swelling or Tightness From Baseline	-2.56	<0.001 sig
SECONDARY Change in Right Leg Tenderness From Baseline	-2.77	<0.001 sig
SECONDARY Change in Left Leg Tenderness From Baseline	-2.71	<0.001 sig
SECONDARY Change in Right Leg Bruising From Baseline	-3.44	<0.001 sig
SECONDARY Change in Left Leg Bruising From Baseline	-3.26	<0.001 sig
SECONDARY Change in Right Leg Redness	-1.79	<0.001 sig
SECONDARY Change in Left Leg Redness	-1.85	<0.001 sig
SECONDARY Change in Fatigue	-3.06	<0.001 sig
SECONDARY Change in Ability to Perform Activities of Daily Living	-2.88	<0.001 sig
SECONDARY Change in the Overall Sense of Wellbeing	-2.47	<0.001 sig
SECONDARY Investigator Assessment of Response to Therapy	3.29	—
SECONDARY Percentage Change Right Leg at 12 Inches	-2.13	0.00463 sig
SECONDARY Percentage Change Left Leg at 2 Inches	0.73	0.23077
SECONDARY Percentage Change Left Leg at 12 Inches	1.92	0.00849 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05616962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.