Status:
COMPLETED
Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
Lead Sponsor:
Izun Pharma Ltd
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 alon...
Detailed Description
This is a multi center, double-blind, randomized, placebo-controlled trial. A total of 80 patients will be randomized according to a 1: 1 randomization schedule. To participate in the trial, patients ...
Eligibility Criteria
Inclusion
- 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
- Wound area decrease of greater than 30% between screening and baseline visits
- Gangrene on any part of the affected foot
- Pregnancy or lactation
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01427569
Start Date
March 1 2012
End Date
August 1 2015
Last Update
December 24 2015
Active Locations (1)
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1
Wolfson Medical Center
Holon, Israel