NCT02598180

VergenixTM Flowable Gel in Patients With Lower Limb Ulcers

Single Arm,Open Label Study, to Evaluate the Safety and Performance of VergenixTM Flowable Gel in Patients With Lower Limb Ulcers (CP-FG-001)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Collplant · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Vergenix Flowable Gel is indicated for the management of acute and chronic wounds

Detailed description

Vergenix™ Flowable Gel is an advanced wound care device primarily made of lyophilized Type I recombinant human Collagen (rhCollagen) . Vergenix Flowable Gel is supplied as a powder contained in a syringe that will be hydrated with saline, forming a gel. The Vergenix™ Flowable Gel provides a scaffold for cellular invasion and capillary growth. A secondary dressing to cover and secure the primary Vergenix™ Flowable Gel wound site followed by a final dressing application that will wrap the wound and surrounding area

Conditions

• Lower Limb Ulcers

Interventions

Type	Name	Description
DEVICE	VergenixTM Flowable Gel	The VergenixTM Flowable Gel is supplied as powder contained in a syringe that will be hydrated with saline.

Timeline

• Start date: 2014-11-25
• Primary completion: 2015-11-02
• Completion: 2015-11-02
• First posted: 2015-11-05
• Last updated: 2019-02-20

Locations

4 sites across 1 country: Israel