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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blind Phase II Study to Evaluate the Efficacy of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: IZN-6D4 Gel
* Other: Placebo hydrogel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IZN-6D4 Gel<br>patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel | Drug: IZN-6D4 Gel<br>* Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.<br>* Other names: Curasite;|
| Placebo Comparator: Placebo Hydrogel<br>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 | Other: Placebo hydrogel<br>* Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel<br>* Other names: Teva Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent reduction in wound area at week 4 compared to the baseline visit |  | Weekly measurements of wound area from study initiation and through week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Chronic wound