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

NCT ID: NCT02361437

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-10-31

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.

Detailed 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.

Conditions

Diabetic Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

placebo

Group Type: PLACEBO_COMPARATOR

Vasculera

Intervention Type: DIETARY_SUPPLEMENT

Vasculera 630 mg b.i.d.

Vasculera

diosmin

Group Type: EXPERIMENTAL

Vasculera

Intervention Type: DIETARY_SUPPLEMENT

Vasculera 630 mg b.i.d.

Interventions

Vasculera

Vasculera 630 mg b.i.d.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

diosmin

Eligibility Criteria

Inclusion Criteria

1. Either gender, between 25-85 years old

2. Diagnosis of type II diabetes

3. 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

4. Treatment with oral anti-diabetic agents and/or insulin for at least 1 year. Dose must be stable for at least 3 months.

5. Not using any other product for control of serum glucose including medical foods, neutraceuticals or dietary supplements

6. Consistent dietary habits

7. Able to understand and sign informed consent document

Exclusion Criteria

1. age less than 25 years or greater than 85 years

2. Skin ulceration of other than diabetic etiology

3. diagnosis of type I diabetes

4. use of any other serum glucose modifying agent, other than stable prescribed anti-diabetic medication regimen within 12 weeks of screening visit

5. use of nutritional supplements specifically for anti-oxidative purposes (e.g., multivitamins allowed)

6. history of collagen vascular disease

7. taking corticosteroids in any dose, by any route

8. no history of therapy with pentoxyphylline or cilostazol for 2 months prior to the screening visit and for the duration of the study

9. history of any intestinal disease that might interfere with absorption of study products

10. 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

11. screening AST, ALT, alkaline phosphatase, bilirubin >1.3 times the upper limit of normal for the reference laboratory

12. serum creatinine >3.0

13. diabetes mellitus not on stable therapy for at least 3 months

14. history of chronic pancreatitis

15. uncontrolled hypertension (DBP >100, SPB >160)

16. unstable angina, other uncontrolled cardiac disease including NYHA CHF Class III or IV

17. pregnant or lactating women

18. known history of allergies to citrus, diosmin, or Alka-4 Complex

19. history of substance abuse, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.

20. 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

21. Concomitant use of chlorzoxazone, diclofenac or metronidazole

22. 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

23. participation in another clinical trial within 30 days or 7 half-lives of the prior study product, whichever is longer, of the screening visit

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Primus Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M Levy, MD

Role: STUDY_DIRECTOR

Primus Pharmaceuticals, Inc

Locations

Nix Hospital

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PVD-01

Identifier Type: -

Identifier Source: org_study_id