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

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Other: Placebo hydrogel; Drug: IZN-6D4 Gel

• Registration Number: NCT01427569
• Lead Sponsor: Izun Pharma Ltd

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 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.

Study Timeline

• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Study Start: 2012-03
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Hydrogel	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
IZN-6D4 Gel	IZN-6D4 Gel	patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 Holon, Israel