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

NCT ID: NCT01427569

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-08-31

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.

Conditions

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Diabetic Foot Ulcer

Keywords

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Diabetes Chronic wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IZN-6D4 Gel

patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel

Group Type EXPERIMENTAL

IZN-6D4 Gel

Intervention Type DRUG

Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.

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

Group Type PLACEBO_COMPARATOR

Placebo hydrogel

Intervention Type OTHER

Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel

Interventions

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IZN-6D4 Gel

Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.

Intervention Type DRUG

Placebo hydrogel

Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel

Intervention Type OTHER

Other Intervention Names

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Curasite Teva Gel

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izun Pharma Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Nussbaum, PhD, MD,

Role: STUDY_DIRECTOR

Izun Pharma Ltd

Locations

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Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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IWH-DFU-101-IL

Identifier Type: -

Identifier Source: org_study_id