NCT01427569

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

A Randomized, Placebo-controlled, Double-blind Phase II Study to Evaluate the Efficacy of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Izun Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 must have a current Diabetic Foot Ulcer (DFU) for between 60 days to 2 years at the screening visit. In the 2-week period between screening and baseline visit, the patient's DFU must not have healed by 30% or more, in wound area, while being treated with SWT twice a week during this screening period. During the treatment period of 4 weeks all patients will be examined on a weekly basis by the site staff. Treatment with SWT plus the study gel (IZN-6D4 Gel or placebo gel) (including any necessary debridement) will be administered at these weekly visits. In addition, the patient or caregiver will be trained to perform SWT plus the study treatment at home once midweek between visits.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	IZN-6D4 Gel	Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.
OTHER	Placebo hydrogel	Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2011-09-01
• Last updated: 2015-12-24

Locations

1 site across 1 country: Israel