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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Izun Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01427569
First received: August 31, 2011
Last updated: December 23, 2015
Last verified: December 2015

August 31, 2011
December 23, 2015
March 2012
July 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.

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.

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 Name: Curasite
  • Other: Placebo hydrogel
    Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel
    Other Name: Teva Gel
  • Experimental: IZN-6D4 Gel
    patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel
    Intervention: Drug: IZN-6D4 Gel
  • 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
    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.
 
Completed
82
August 2015
July 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 information is only displayed when the study is recruiting subjects
Israel
 
NCT01427569
IWH-DFU-101-IL
No
Not Provided
Not Provided
Izun Pharma Ltd
Izun Pharma Ltd
Not Provided
Study Director: Gabriel Nussbaum, PhD, MD, Izun Pharma Ltd
Izun Pharma Ltd
December 2015

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