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

Primus Pharmaceuticals

Status

Withdrawn

Conditions

Diabetic Ulcers

Treatments

Dietary Supplement: Vasculera

Study type

Interventional

Funder types

Industry

Identifiers

NCT02361437

PVD-01

Details and patient eligibility

About

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

Full description

This study is designed primarily to compare the rate and extent of healing of diabetic ulcers in people treated with or without Vasculera while maintaining a standard of care (SOC) therapeutic regimen. The study will also examine the effects of Vasculera on anti-diabetic medication requirements and markers of microvascular disease. Subjects will be stratified by whether or not they receive hyperbaric oxygen therapy (HBOT) as part of their SOC treatment regimen. In addition, the study will examine the ability of Vasculera to improve glycemic control and reduce anti-diabetic medication requirements (oral or injectable insulin) and will gather preliminary information on the ability of Vasculera to improve microvascular blood flow and oxygen delivery peripheral tissues including ulcerative lesions.

Sex

All

Ages

25 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)
unstable angina, other uncontrolled cardiac disease including NYHA CHF Class III or IV
pregnant or lactating women
known history of allergies to citrus, diosmin, or Alka-4 Complex
history of substance abuse, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
Consumption of more than one (1) unit of alcohol daily. For the purposes of this study a unit of alcohol is defined as 12 oz. of beer, 6 oz. of wine or 1.5 oz. of hard spirits
Concomitant use of chlorzoxazone, diclofenac or metronidazole
any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study
participation in another clinical trial within 30 days or 7 half-lives of the prior study product, whichever is longer, of the screening visit