Safety and Efficacy of Topical AR/101 Compared With Placebo, in Accelerating Granulation Tissue Formation of Hard-to-heal Wounds

July 19, 2016 updated by: Arava Bio Tech Ltd.

Prospective, Placebo-controlled, Double-blind, Randomized Clinical Study to Assess the Safety and Efficacy of Topical Treatment of AR/101 Compared With for up to 28 Days, in Accelerating Granulation Tissue Formation in Chronic Wound Patients

This prospective, placebo-controlled, double blind, randomized study is designed to assess the healing effects of AR/101 on chronic Hard-to-Heal wound(s) of different etiologies including arterial ulcers, diabetic ulcers and venous ulcers, of at least 3 months duration. After collection of comprehensive medical data to confirm eligibility of patient and obtaining informed consent , patients will enter Screening run-in Period where all wounds will be cleaned if necessary by surgical debridement and irrigation (isotonic solution) prior to initiation (run-in phase) of the study according to physician's instructions. During the 14 day screening period, all subjects will receive standard of care (SoC) on a daily basis, as per indication and patients status, according to physicians instructions. Wounds will be morphologically assessed by the treating physician and by photographic evaluation by the PI once a week - at days 7 and 14 of the screening run-in phase. Following the run-in period, Subjects with wounds of ≥ 5cm2 and ≤100 cm2 of at least 3 months duration that fail to respond to treatment with SoC during the screening run-in phase will be enrolled into the study. Eligible subjects with wounds will be randomized and treated topically with AR/101+ SoC or placebo +SoC once daily for up to 14 days. During this treatment phase I, depending on their wound size and wound type, subjects will receive treatment dose applied topically daily and wounds will be dressed according to physician's instructions. Wounds will be photographed daily and assessed by the treating physician in the clinic once a week (at the end of each weekly period). During the treatment period, adverse events and concomitant medications will be monitored; wounds will be morphologically assessed by photo documentation and followed for wound bed progression and granulation tissue formation. At the end of Treatment period I, patient's wounds will be analyzed and all patients from both treatment arms with wound score 0-2 will be assigned to receive the study drug for and additional up to 14 days treatment phase II in full accordance with the treatment regimen described in Treatment phase I. A termination visit will be performed at day 14 of Treatment phase I or II or earlier if the wound has reached the maximum score on the granulation scale or if the wound is ready for skin grafting; or in any case of early withdrawal that is not due to withdrawal of consent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Tel Aviv, Israel, 96105
        • Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is 18 years old and above
  2. Have single/multiple wounds
  3. Have a chronic hard to heal wound of various etiologies for at least 3 months of duration
  4. Patient was treated for 14 days with SoC (screening run-in) and did not respond to treatment. "Response" is defined as formation of more than 10% of viable granulation tissue.
  5. Wound area is larger than 5cm2 and smaller than 100 cm2.
  6. Subject should be available for the entire study period, and be able and willing to adhere to protocol requirements
  7. Subject must sign an informed consent form prior to undergoing any study- related procedures.
  8. For female subjects only, the subject is either:

A. Surgically sterile B. At least 1 year post-menopausal.

C. Subject has consented to using one of the following acceptable methods of birth control for the times specified below:

  • Intra-uterine device (IUD) in place for at least 3 months prior to screening visit and through study completion.
  • Barrier method (condom or diaphragm) for at least 14 days prior to screening through study completion.
  • Spermicide for at least 14 days prior to screening through study completion.
  • Stable hormonal contraceptive for at least 3 months prior to screening visit through study completion.
  • Surgical Sterilization (vasectomy) of partner at least 6 months prior to screening visit through study completion.

Exclusion Criteria:

  1. Have a documented medical history of a significant hematological, cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), or hepatic disease which per the physician's discretion prohibit them from entering the study.
  2. Had any clinically significant illness per the physician's discretion during the last 4 weeks prior to the screening period.
  3. Have a documented medical history . of HBV, HCV, HIV.
  4. Severely immunosuppressed for any reason that would limit or preclude healing in the opinion of the Investigator.
  5. Patient is currently receiving, or has received at any time within one month prior to enrollment, any medications or treatments known to affect the wound healing processes including Glucocorticosteroid treatment (Prednisone > 10mg/day or its equivalent), immuno-suppressive drugs, radiation therapy and chemotherapy.
  6. Use of growth factors, allogeneic skin grafts/ skin graft products within one month prior to enrollment.
  7. Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 1 year and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a blood-based pregnancy test.
  8. Clinically significant blood and urinalysis tests per the physician's discretion.
  9. Have any acute signs of infection in the wound, which could be linked to raised body temperature, abscess, necrosis, cellulitis or acute osteomyelitis.
  10. Have sinus tracts or tunnels, purulent discharge , gangrene or severe drainage that will cause skin maceration per the physician's discretion.
  11. Had any antibiotic treatment for acute infection during the screening period (prophylactic antibiotic treatment is allowed)
  12. Intolerance to compression therapy if required for venous ulcers or inability to follow SoC according to the physician's instructions.
  13. Had revascularization surgery during the past 3 months or be a candidate for revascularization surgery during the course of the study.
  14. Active wound care therapies within the past 3 months (e.g., manufactured dermis, full-thickness skin, Becaplermin, split thickness autologous skin grafts at the site of the target wound)
  15. Patients with poor nutritional status (albumin < 2.5g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin<8 g/dL), a leukocyte counts < 4,000// μl or >15000/μl, renal failure (Cr > 3 mg/dl);
  16. Active deep venous thrombosis (DVT)
  17. Patients with uncontrollable edema >+2
  18. Patients who in the opinion of the investigator, for any reason other than those listed above will not be able to complete the study per protocol.
  19. Participation in another clinical trial within 30 days prior to the Screening period or during this study.

  20. History of mental illness that would preclude completion of the study

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: AR/101
AR/101 will be administered topically once daily for up to 28 days concomitantly with standard of care as advised by treating physician. After randomization, patients will be treated for up-to 28 days, or until granulation tissue formation has reached maximal score on the granulation scale, or until the wound is ready for skin grafting, whichever occurs first.
Drug: AR/101
Placebo Comparator: Placebo
placebo will be administered topically once daily for up to 28 days concomitantly with standard of care as advised by treating physician. After randomization, patients will be treated for up-to 14 days or until granulation tissue formation has reached maximal score on the granulation scale, or until the wound is ready for skin grafting, whichever occurs first.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
comparison of the formation of new granulation tissue according to a Granulation Score, between the AR/101 treated group and the placebo group, during the treatment phases
Time Frame: 28 days
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients ready for skin grafting or healing by secondary intention during treatment phase 1 and treatment phase 2 based on physician's assessment
Time Frame: 28 days
28 days
Percent of patient responders of equal or more then 75% granulation tissue during two weeks of treatment phase 1
Time Frame: 14 days
14 days
Mean time to response (equal or more then 75% of granulation tissue) during two weeks of treatment phase 1
Time Frame: 14 days
14 days
Mean time to response (equal or more then 75% of granulation tissue) during two weeks of treatment phase 2
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arava Bio Tech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AR-H2H-2016-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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