Status and phase
Conditions
Treatments
About
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.
Enrollment
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Ages
Volunteers
Inclusion criteria
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:
Exclusion criteria
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.
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
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups, including a placebo group
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Central trial contact
Tamar Tennenbaum, MD; Adi Dagan
Data sourced from clinicaltrials.gov
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