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A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's

Diabetic Foot Ulcer Clinical Trial

Official title:
A Multi-center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

Clinical Trial Summary

The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the primary dressing. Both products are 510(k) FDA cleared and will be used within the cleared intended use.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05193929
Study type Interventional
Source Compedica Inc
Contact Daniel Blackman
Phone +44 (0)7809144960
Email Daniel.blackman@Compedica.com
Status Recruiting
Phase N/A
Start date December 15, 2021
Completion date December 15, 2024
View Details
See also
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