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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01427569
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: IZN-6D4 Gel Other: Placebo hydrogel Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2012
Primary Completion Date : July 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Teva Gel


Outcome Measures

Primary Outcome Measures :
  1. The percent reduction in wound area at week 4 compared to the baseline visit [ Time Frame: Weekly measurements of wound area from study initiation and through week 4 ]

Secondary Outcome Measures :
  1. The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline [ Time Frame: Weekly assessments from baseline through week 4 ]
  2. The percentage of lesions that demonstrate at least 40% reduction in area by the end of week 4 compared to baseline visit [ Time Frame: Weekly assessments of wound area through week 4 ]
  3. The percentage of lesions that demonstrate at least 50% reduction in area by the end of week 4 compared to baseline visit [ Time Frame: Weekly assessments of wound area from baseline through week 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427569


Locations
Israel
Wolfson Medical Center
Holon, Israel
Sponsors and Collaborators
Izun Pharma Ltd
Investigators
Study Director: Gabriel Nussbaum, PhD, MD, Izun Pharma Ltd
More Information

Responsible Party: Izun Pharma Ltd
ClinicalTrials.gov Identifier: NCT01427569     History of Changes
Other Study ID Numbers: IWH-DFU-101-IL
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015

Keywords provided by Izun Pharma Ltd:
Diabetes
Chronic wound

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases