Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)

The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). The main questions it aims to answer are: * First, what medical problems do participants have after taking drug NL003 to treat CLI? * Second, does drug NL003 make CLI participants live longer without serious problems (amputations or target vessel revascularizations) ? Participants who have already received drug NL003 for CLI will complete online surveys about their health conditions. This study will continue until at least 36 months after the participant's first dose.

NCT Number	NCT07023965
Lead Sponsor	Beijing Northland Biotech. Co., Ltd.
Conditions	Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans, Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Ischemic, Critical Limb Ischemia (CLI)
Enrollment	542 participants
Start Date	2025-06-30
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-11