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Medical Food

Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers

N/A
Waitlist Available
Research Sponsored by Primus Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months

Summary

This study is designed to evaluate if Vasculera, a marketed medical food product, will improve the rate and extent of healing of diabetic ulcers.

Eligible Conditions
  • Foot Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of healing of diabetic ulcers measured by ulcer size
Secondary study objectives
Efficacy of diabetic control measure by reduction of oral anti-diabetic medication and/or insulin requirements
Edema
lower extremity skin oxygenation measured by trancutaneous oximetry

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VasculeraExperimental Treatment1 Intervention
diosmin
Group II: placeboPlacebo Group1 Intervention
placebo

Find a Location

Who is running the clinical trial?

Primus PharmaceuticalsLead Sponsor
21 Previous Clinical Trials
2,356 Total Patients Enrolled
Robert M Levy, MDStudy DirectorPrimus Pharmaceuticals, Inc
1 Previous Clinical Trials
350 Total Patients Enrolled
~0 spots leftby Dec 2025
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