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

NCT01427569 | Completed Phase 2

• 1 other identifier: IWH-DFU-101-IL
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; Chronic wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

IZN-6D4 Gel

EXPERIMENTAL

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

Drug: IZN-6D4 Gel

Placebo Hydrogel

PLACEBO COMPARATOR

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

Interventions

IZN-6D4 Gel DRUG

Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.

Also known as: Curasite

IZN-6D4 Gel

Placebo hydrogel OTHER

Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel

Also known as: Teva Gel

Placebo Hydrogel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Wound area decrease of greater than 30% between screening and baseline visits
• Gangrene on any part of the affected foot
• Pregnancy or lactation

Sponsors & Collaborators

• Izun Pharma Ltd: lead

Study Sites (1)

Wolfson Medical Center

Holon, Israel

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gabriel Nussbaum, PhD, MD,

  Izun Pharma Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 1, 2011
• Study Start: March 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

IL (1)