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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427569
• Other study ID #: IWH-DFU-101-IL
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2011
• Last updated: December 23, 2015
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Izun Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Izun Pharma Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline		Weekly assessments from baseline through week 4	No
Secondary	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	No
Secondary	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	No