Diabetic Foot UlcerPhase 2NCT01427569
Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
A Phase 2 study testing IZN-6D4 Gel in people with Diabetic Foot Ulcer, run by Izun Pharma Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- IZN-6D4 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Wound area decrease of greater than 30% between screening and baseline visits
- Gangrene on any part of the affected foot
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- IZN-6D4 Gel, Placebo hydrogel
- Keywords
- Diabetes, Chronic wound
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IZN-6D4 GelDrug
Also called Curasite
Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.
Placebo hydrogelOther
Also called Teva Gel
Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel
| Study group | Role | What they receive |
|---|---|---|
| IZN-6D4 Gel | Experimental | patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel Receives: Drug: IZN-6D4 Gel |
| Placebo Hydrogel | Placebo comparator | 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 Receives: Other: Placebo hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent reduction in wound area at week 4 compared to the baseline visit
Measured: Weekly measurements of wound area from study initiation and through week 4
Secondary outcomes (3)
The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline
Measured: 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
Measured: 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
Measured: Weekly assessments of wound area from baseline through week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izun Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Nussbaum, PhD, MD,, Study director, Izun Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427569
- Sponsor's protocol ID
- IWH-DFU-101-IL
- Status last verified
- Dec 2015
- First submitted
- 31 Aug 2011
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01427569
- Acronym / sponsor ID
- IWH-DFU-101-IL
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, Chronic wound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Izun Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IZN-6D4 Gel | Experimental | Drug: IZN-6D4 Gelpatients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel |
| Placebo Hydrogel | Placebo comparator | Other: Placebo hydrogelpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Wound area decrease of greater than 30% between screening and baseline visits
- Gangrene on any part of the affected foot
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IZN-6D4 GelAlso: CurasiteStandard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts. | Drug | IZN-6D4 Gel |
| Placebo hydrogelAlso: Teva GelStandard wound therapy plus twice weekly topical application of color-matched placebo hydrogel | Other | Placebo Hydrogel |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Nussbaum, PhD, MD, study director
Izun Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IZN-6D4 Gel in people with Diabetic Foot Ulcer, run by Izun Pharma Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.