Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Izun Pharma Ltd

Criteria

Inclusion Criteria:

• Current diagnosis of diabetes mellitus type 1 or 2

• Foot ulcer Wagner grade 1 or 2

• Ulcer between 1 square cm and 8 square cm present for at least 60 days and not more than two years

• HgbA1C less than 10%

• Able to comply with all procedures

Exclusion Criteria:

• Wound area decrease of greater than 30% between screening and baseline visits

• Gangrene on any part of the affected foot

• Pregnancy or lactation