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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Izun Pharma Ltd
Sponsor:
Information provided by (Responsible Party):
Izun Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01427569
First received: August 31, 2011
Last updated: October 6, 2014
Last verified: October 2014

August 31, 2011
October 6, 2014
March 2012
June 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01427569 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
A Randomized, Placebo-controlled, Double-blind Phase II Study to Evaluate the Efficacy of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • 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
  • Experimental: IZN-6D4 Gel
    Intervention: Drug: IZN-6D4 Gel
  • Placebo Comparator: Placebo Gel
    Intervention: Other: Placebo hydrogel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kfir Gazit, Phd., CRA +972-72-2456173 kfir@izunpharma.com
Contact: Rafael Weisz, BSc., CRA +972-2456199 rafael@izunpharma.com
Israel
 
NCT01427569
IWH-DFU-101-IL
No
Izun Pharma Ltd
Izun Pharma Ltd
Not Provided
Not Provided
Izun Pharma Ltd
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP