WoundsPhase 2NCT02839226
Safety and Efficacy of Topical AR/101 Compared With Placebo, in Accelerating Granulation Tissue Formation of Hard-to-heal Wounds
A Phase 2 study testing AR/101 in people with Wounds and Other Ulcers Wounds and Skin Problems, run by Arava Bio Tech Ltd. at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds, Other Ulcers Wounds and Skin Problems
- What is being tested?
- AR/101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to Dec 2017
- 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
- Subject is 18 years old and above
- Have single/multiple wounds
- Have a chronic hard to heal wound of various etiologies for at least 3 months of duration
- 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.
- Wound area is larger than 5cm2 and smaller than 100 cm2.
- Subject should be available for the entire study period, and be able and willing to adhere to protocol requirements
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- Subject must sign an informed consent form prior to undergoing any study- related procedures.
- For female subjects only, the subject is either:
- Surgically sterile B. At least 1 year post-menopausal.
- 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.
Who cannot join
- 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.
- Had any clinically significant illness per the physician's discretion during the last 4 weeks prior to the screening period.
- Have a documented medical history . of HBV, HCV, HIV.
- Severely immunosuppressed for any reason that would limit or preclude healing in the opinion of the Investigator.
- 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.
- Use of growth factors, allogeneic skin grafts/ skin graft products within one month prior to enrollment.
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- 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.
- Clinically significant blood and urinalysis tests per the physician's discretion.
- Have any acute signs of infection in the wound, which could be linked to raised body temperature, abscess, necrosis, cellulitis or acute osteomyelitis.
- Have sinus tracts or tunnels, purulent discharge , gangrene or severe drainage that will cause skin maceration per the physician's discretion.
- Had any antibiotic treatment for acute infection during the screening period (prophylactic antibiotic treatment is allowed)
- Intolerance to compression therapy if required for venous ulcers or inability to follow SoC according to the physician's instructions.
- Had revascularization surgery during the past 3 months or be a candidate for revascularization surgery during the course of the study.
- 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)
- 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);
- Active deep venous thrombosis (DVT)
- Patients with uncontrollable edema >+2
- 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.
- Participation in another clinical trial within 30 days prior to the Screening period or during this study.
- History of mental illness that would preclude completion of the study
- -
Trial locations and contacts
1 site in 1 country.
Tamar Tennenbaum, MD contact
Adi Dagan contact
Israel1 site
Sourasky Medical Center
Tel Aviv, 96105
Eyal Gur, MD, Gur@tlvmc.gov.il
Meirav Sela, MSc, meiravs@tlvmc.gov.il
About this study
Official title: 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.
- Conditions
- Wounds, Other Ulcers Wounds and Skin Problems
- Being tested
- AR/101, Placebo
- Keywords
- ulcers, wounds, diabetes, venous ulcers, arterial ulcers, granulation tissue, protein kinase c
- Medical subject headings
- Wounds and Injuries, Ulcer, Diabetes Mellitus, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR/101Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AR/101 | Active comparator | 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. Receives: Drug: AR/101 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (4)
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
Measured: 28 days
Percent of patient responders of equal or more then 75% granulation tissue during two weeks of treatment phase 1
Measured: 14 days
Mean time to response (equal or more then 75% of granulation tissue) during two weeks of treatment phase 1
Measured: 14 days
Mean time to response (equal or more then 75% of granulation tissue) during two weeks of treatment phase 2
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arava Bio Tech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839226
- Sponsor's protocol ID
- AR-H2H-2016-04
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02839226
- Acronym / sponsor ID
- AR-H2H-2016-04
- Conditions
- Wounds, Other Ulcers Wounds and Skin Problems
- Keywords
- ulcers, wounds, diabetes, venous ulcers, arterial ulcers, granulation tissue, protein kinase c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Arava Bio Tech Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Jul 2016 (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.
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 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 |
|---|---|---|
| AR/101 | Active comparator | Drug: AR/101AR/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. |
| Placebo | Placebo comparator | Drug: Placeboplacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject is 18 years old and above
- Have single/multiple wounds
- Have a chronic hard to heal wound of various etiologies for at least 3 months of duration
- 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.
- Wound area is larger than 5cm2 and smaller than 100 cm2.
Key exclusion criteria (21 listed)
- 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.
- Had any clinically significant illness per the physician's discretion during the last 4 weeks prior to the screening period.
- Have a documented medical history . of HBV, HCV, HIV.
- Severely immunosuppressed for any reason that would limit or preclude healing in the opinion of the Investigator.
- 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.
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 |
|---|---|---|
| AR/101 | Drug | AR/101 |
| Placebo | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
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
Percent of patient responders of equal or more then 75% granulation tissue during two weeks of treatment phase 1
Time frame: 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
Mean time to response (equal or more then 75% of granulation tissue) during two weeks of treatment phase 2
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
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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.
Tamar Tennenbaum, MD contact
Adi Dagan contact
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 AR/101 in people with Wounds and Other Ulcers Wounds and Skin Problems, run by Arava Bio Tech 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 15 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 20 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamar Tennenbaum, MD (tamar@arava-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 20 Jul 2016.