A Randomized, Placebo-controlled, Double-blind Phase II Study to Evaluate the Efficacy of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
Overview
- Phase
- Phase 2
- Intervention
- IZN-6D4 Gel
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- Izun Pharma Ltd
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- The percent reduction in wound area at week 4 compared to the baseline visit
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
IZN-6D4 Gel
patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel
Intervention: IZN-6D4 Gel
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: Placebo hydrogel
Outcomes
Primary Outcomes
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 Outcomes
- The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline(Weekly assessments from baseline through week 4)
- The percentage of lesions that demonstrate at least 40% reduction in area by the end of week 4 compared to baseline visit(Weekly assessments of wound area through week 4)
- The percentage of lesions that demonstrate at least 50% reduction in area by the end of week 4 compared to baseline visit(Weekly assessments of wound area from baseline through week 4)