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

Plain-language 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. 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.

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