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

Primary Purpose

Diabetic Foot Ulcer

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

IZN-6D4 Gel

Placebo hydrogel

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetes, Chronic wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wolfson Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IZN-6D4 Gel

Placebo Hydrogel

Arm Description

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

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

Outcomes

Primary Outcome Measures

The percent reduction in wound area at week 4 compared to the baseline visit

Secondary Outcome Measures

The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline

The percentage of lesions that demonstrate at least 40% reduction in area by the end of week 4 compared to baseline visit

The percentage of lesions that demonstrate at least 50% reduction in area by the end of week 4 compared to baseline visit

Full Information

NCT ID

NCT01427569

First Posted

August 31, 2011

Last Updated

December 23, 2015

Sponsor

Izun Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01427569

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Izun Pharma Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

Keywords

Diabetes, Chronic wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IZN-6D4 Gel

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Hydrogel

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

IZN-6D4 Gel

Other Intervention Name(s)

Curasite

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo hydrogel

Other Intervention Name(s)

Teva Gel

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriel Nussbaum, PhD, MD,

Organizational Affiliation

Izun Pharma Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Wolfson Medical Center

City

Holon

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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