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

NCT02361437 | Withdrawn

• 1 other identifier: PVD-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Ulcers

Keywords

diabetes type II; diabetic ulcers

Outcome Measures

Primary Outcomes (1)

• Rate of healing of diabetic ulcers measured by ulcer size

  days to complete healinh

  4 months

Secondary Outcomes (3)

• Efficacy of diabetic control measure by reduction of oral anti-diabetic medication and/or insulin requirements

  4 months

• Reduction on peripheral edema measured by leg circumferance

  4 months

• lower extremity skin oxygenation measured by trancutaneous oximetry

  4 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Vasculera

Vasculera

EXPERIMENTAL

diosmin

Dietary Supplement: Vasculera

Interventions

Vasculera DIETARY_SUPPLEMENT

Vasculera 630 mg b.i.d.

Also known as: diosmin

Vasculera; placebo

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either gender, between 25-85 years old
• Diagnosis of type II diabetes
• Presence of a grade I-III skin ulcer of diabetic origin and at least 1 cm in diameter for more than 60 days and not improving despite standard conventional care without HBOT
• Treatment with oral anti-diabetic agents and/or insulin for at least 1 year. Dose must be stable for at least 3 months.
• Not using any other product for control of serum glucose including medical foods, neutraceuticals or dietary supplements
• Consistent dietary habits
• Able to understand and sign informed consent document

You may not qualify if:

• age less than 25 years or greater than 85 years
• Skin ulceration of other than diabetic etiology
• diagnosis of type I diabetes
• use of any other serum glucose modifying agent, other than stable prescribed anti-diabetic medication regimen within 12 weeks of screening visit
• use of nutritional supplements specifically for anti-oxidative purposes (e.g., multivitamins allowed)
• history of collagen vascular disease
• taking corticosteroids in any dose, by any route
• no history of therapy with pentoxyphylline or cilostazol for 2 months prior to the screening visit and for the duration of the study
• history of any intestinal disease that might interfere with absorption of study products
• any active malignancy or history of malignancy within 3 years of the screening visit,, except basal cell carcinoma or cervical carcinoma in situ curatively treated
• screening AST, ALT, alkaline phosphatase, bilirubin \>1.3 times the upper limit of normal for the reference laboratory
• serum creatinine \>3.0
• diabetes mellitus not on stable therapy for at least 3 months
• history of chronic pancreatitis
• uncontrolled hypertension (DBP \>100, SPB \>160)

Sponsors & Collaborators

• Primus Pharmaceuticals: lead

Study Sites (1)

Nix Hospital

San Antonio, Texas, 78205, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert M Levy, MD

  Primus Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 11, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 19, 2024

Record last verified: 2015-10

Locations

US (1)