NCT03699072

DermaRep™ Device in the Treatment of Venous Leg Ulcers

A Multi-centre, Pilot, Prospective Trial of DermaRep™ Device in the Treatment of Venous Leg Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Biovotec AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. All patients will then be treated with DermaRep™ wound contact dressing in addition to standard of care for a further 8 weeks. If the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. All patients will be assessed at the 16 week timepoint, the primary endpoint.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	DermaRep™ Wound Contact Device	Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings

Timeline

• Start date: 2018-11-05
• Primary completion: 2020-04-01
• Completion: 2020-09-16
• First posted: 2018-10-09
• Last updated: 2020-12-16

Locations

6 sites across 1 country: United Kingdom