- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361437
Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers
December 11, 2017 updated by: Primus Pharmaceuticals
Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers and Improving Insulin Sensitivity: A Pilot Study
This study is designed to evaluate if Vasculera, a marketed medical food product, will improve the rate and extent of healing of diabetic ulcers.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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San Antonio, Texas, United States, 78205
- Nix Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
Vasculera 630 mg b.i.d.
Other Names:
|
Experimental: Vasculera
diosmin
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Vasculera 630 mg b.i.d.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of healing of diabetic ulcers measured by ulcer size
Time Frame: 4 months
|
days to complete healinh
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of diabetic control measure by reduction of oral anti-diabetic medication and/or insulin requirements
Time Frame: 4 months
|
anti-diabetic medication doses
|
4 months
|
Reduction on peripheral edema measured by leg circumferance
Time Frame: 4 months
|
leg circumference
|
4 months
|
lower extremity skin oxygenation measured by trancutaneous oximetry
Time Frame: 4 months
|
transcutaneous oximetry at toes
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert M Levy, MD, Primus Pharmaceuticals, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
February 4, 2015
First Submitted That Met QC Criteria
February 6, 2015
First Posted (Estimate)
February 11, 2015
Study Record Updates
Last Update Posted (Actual)
December 13, 2017
Last Update Submitted That Met QC Criteria
December 11, 2017
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PVD-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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