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

This study is currently recruiting participants.
Verified May 2012 by Izun Pharma Ltd
Sponsor:
Information provided by (Responsible Party):
Izun Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01427569
First received: August 31, 2011
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetic Foot Ulcer
 Drug: IZN-6D4 Gel
Other: Placebo hydrogel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Izun Pharma Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IZN-6D4 Gel Drug: IZN-6D4 Gel
Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.
Placebo Comparator: Placebo Gel Other: Placebo hydrogel
Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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 180 days
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427569

Contacts
Contact: Haia van Gelderen, BSc, RN +972-2-5860780 haia@izunpharma.com

Locations
Israel
Wolfson Medical Center Recruiting
Holon, Israel
Principal Investigator: Zeev Feldbrin, MD            
Sponsors and Collaborators
Izun Pharma Ltd
  More Information

No publications provided

Responsible Party: Izun Pharma Ltd
ClinicalTrials.gov Identifier: NCT01427569     History of Changes
Other Study ID Numbers: IWH-DFU-101-IL
Study First Received: August 31, 2011
Last Updated: May 23, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Izun Pharma Ltd:
Diabetes
Chronic wound

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

ClinicalTrials.gov processed this record on June 18, 2013