NCT02361437

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Primus Pharmaceuticals · Industry
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vasculera	Vasculera 630 mg b.i.d.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-02-11
• Last updated: 2024-04-19

Locations

1 site across 1 country: United States