Trial Profile

A phase 3 randomized, double-blind, placebo-controlled trial of intralesional recombinant human Epidermal Growth Factor (rhEGF) for the treatment of complex and complicated refractory neuropathic, ischemic, and neuroischemic diabetic foot ulcers (DFU)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 07 May 2024

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At a glance

07 May 2024 New trial record
30 Apr 2024 According to a Discovery Therapeutics Caribe media release, company believes they are on track to initiate this pivotal U.S.-based trial of intralesional rhEGF by year-end 2024.
30 Apr 2024 According to a Discovery Therapeutics Caribe media release, in the first quarter of 2024, DTC submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA). The FDA completed its review of the IND and concluded that DTC may proceed with its proposed Phase 3 clinical investigation. DTC received a Study May Proceed (SMP) letter from the FDA on April 10, 2024.

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