NCT06150209

A Controlled Prospective Treatment Study to Evaluate the Efficacy of Vendaje.

A Controlled Data Collection and Prospective Treatment Study to Evaluate the Efficacy of Vendaje in the Management of Foot Ulcers in Diabetic Patients.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: BioStem Technologies · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Goal of this study is to evaluate the wound volume reduction rate and the time to closure when using Vendaje to manage diabetic wounds. The participants will be treated weekly for up to 12 weeks. The data will be compared to retrospective Standard of care data from similarly controlled studies

Detailed description

Patients will be recruited by the site PIs and will be educated on the details of the study through the use of a detailed And IRB approved informed consent. They must meet the inclusion/exclusion criteria which includes appropriate testing for perfusion and control of diabetes. Once accepted a screening visit without Vendaje treatment but SOC treatment to determine if closure with SOC will be adequate. If the SOC screen fails a threat protocol begins for up to 12 weeks or closure. data will be collected using digital planimetry and also recorded in a research binder with CRFs provided. A final visit 2 weeks after closure or end of 12 weeks will provided information related to wound recurrence.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Vendaje	Dehydrated Human Amniotic Membrane

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-12-15
• Completion: 2025-06-15
• First posted: 2023-11-29
• Last updated: 2023-11-29