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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: IZN-6D4 Gel; Other: Placebo hydrogel

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel
    • Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IZN-6D4 Gel; patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel	Drug: IZN-6D4 Gel; Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.; Other Names: Curasite
Placebo Comparator: Placebo Hydrogel; patients in this arm will be treated by twice a week bandaging the wound with a hydrogel used for wound care, but without the active IZN-6D4	Other: Placebo hydrogel; Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel; Other Names: Teva Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percent reduction in wound area at week 4 compared to the baseline visit	Weekly measurements of wound area from study initiation and through week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline	Weekly assessments from baseline through week 4
The percentage of lesions that demonstrate at least 40% reduction in area by the end of week 4 compared to baseline visit	Weekly assessments of wound area through week 4
The percentage of lesions that demonstrate at least 50% reduction in area by the end of week 4 compared to baseline visit	Weekly assessments of wound area from baseline through week 4

Collaborators and Investigators

• Sponsor: Izun Pharma Ltd
• Investigators: Study Director: Gabriel Nussbaum, PhD, MD,, Izun Pharma Ltd

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: August 31, 2011
• First Posted (Estimate): September 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes; Chronic wound
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: IWH-DFU-101-IL