Clinical trial NCT01427569: Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes
Chronic wound
Lead sponsor: Izun Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The percent reduction in wound area at week 4 compared to the baseline visit
timeFrame: Weekly measurements of wound area from study initiation and through week 4
Secondary outcomes:
measure: The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline
timeFrame: Weekly assessments from baseline through week 4
measure: The percentage of lesions that demonstrate at least 40% reduction in area by the end of week 4 compared to baseline visit
timeFrame: Weekly assessments of wound area through week 4
measure: The percentage of lesions that demonstrate at least 50% reduction in area by the end of week 4 compared to baseline visit
timeFrame: Weekly assessments of wound area from baseline through week 4
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
affiliation: Izun Pharma Ltd
name: Gabriel Nussbaum, PhD, MD,
role: STUDY_DIRECTOR
References: