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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers and Improving Insulin Sensitivity: A Pilot Study

Conditions
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Diabetic Ulcers

Intervention / Treatment
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* Dietary Supplement: Vasculera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Dietary Supplement: Vasculera<br>* Vasculera 630 mg b.i.d.<br>* Other names: diosmin;|
| Experimental: Vasculera<br>diosmin | Dietary Supplement: Vasculera<br>* Vasculera 630 mg b.i.d.<br>* Other names: diosmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of healing of diabetic ulcers measured by ulcer size | 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 | anti-diabetic medication doses | 4 months | 
| Reduction on peripheral edema measured by leg circumferance | leg circumference | 4 months | 
| lower extremity skin oxygenation measured by trancutaneous oximetry | transcutaneous oximetry at toes | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes type II, diabetic ulcers