NCT02631512

Evaluation of Woulgan in Diabetic Foot Ulcer

Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Biotec Pharmacon ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	Woulgan Gel	Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
DEVICE	Intrasite Hydrogel	Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-12-31
• Completion: 2019-04-30
• First posted: 2015-12-16
• Last updated: 2019-05-30

Locations

3 sites across 2 countries: Sweden, United Kingdom