Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia

Trial details

Who runs it

First Affiliated Hospital of Wenzhou Medical University

Trial code

NCT07827521

Record updated

18 September 2026

Original description

The goal of this clinical trial is to learn whether Seltoplasmid Injection can improve outcomes after lower-extremity revascularization. Revascularization is a procedure used to restore blood flow to the leg. The study will include adults with type 2 diabetes, a foot ulcer caused by poor blood flow, and disease mainly affecting the arteries below the knee.Read full original descriptionShow less

A Multicenter, Randomized, Open-Label, Controlled Trial to Evaluate the Safety and Efficacy of Seltoplasmid Injection Combined With Revascularization for Chronic Limb-Threatening Ischemia Caused by Infrapopliteal Artery Disease in Patients With Diabetes

The goal of this clinical trial is to learn whether Seltoplasmid Injection can improve outcomes after lower-extremity revascularization. Revascularization is a procedure used to restore blood flow to the leg. The study will include adults with type 2 diabetes, a foot ulcer caused by poor blood flow, and disease mainly affecting the arteries below the knee.

The main questions are:

* Does adding Seltoplasmid lower the risk of major amputation, another procedure to restore blood flow, or death? * What medical problems occur after treatment with Seltoplasmid? About 180 participants will undergo standard lower-extremity revascularization. After the procedure, eligible participants will be assigned by chance to one of two groups. One group will receive Seltoplasmid plus standard care. The other group will receive standard care alone.

Participants in the Seltoplasmid group will receive injections into the muscles of the affected lower leg. The injections will be given on Day 0, Day 14, and Day 28.

Participants will be followed for 12 months. Researchers will also assess wound healing, survival without amputation, heart and blood vessel problems, pain, and blood flow in the affected leg.

Inclusion: Male or female, aged 18 years or older at the time of signing informed consent; Clinical diagnosis of type 2 diabetes mellitus with a diabetic foot ulcer and chronic limb-threatening ischemia classified as Rutherford category 5. The target limb must have an ischemic foot ulcer corresponding to WIfI wound grade 1 or 2. After at least 2 weeks of optimal standard wound care, including debridement, offloading, and infection control as clinically indicated, the ulcer must show no clear healing tendency, defined as a reduction in area of less than 30%, and infrapopliteal revascularization must be considered necessary to improve perfusion and promote wound healing; Color duplex ultrasonography, computed tomography angiography (CTA), or digital subtraction angiography (DSA) demonstrates at least 70% stenosis or occlusion in one or more infrapopliteal arteries, the anterior tibial, posterior tibial, or peroneal artery, and the investigator considers this disease to be the principal cause of ischemia in the target limb; No severe stenosis in the supra-popliteal inflow arteries, including the iliac, femoral, and popliteal arteries, defined as less than 70% stenosis; alternatively, any severe inflow stenosis can be treated during the index procedure. The infrapopliteal lesion or lesions must remain the principal revascularization target; Objective evidence of severe limb ischemia meeting at least one of the following criteria: ankle-brachial index (ABI) ≤0.50; ankle systolic pressure measured at the dorsalis pedis or posterior tibial artery ≤70 mmHg; or transcutaneous oxygen pressure (TcPO₂) <30 mmHg. If ABI is >1.30 or otherwise considered unreliable because of arterial incompressibility, eligibility will be determined using toe-brachial index (TBI), toe pressure where available, and/or TcPO₂; Willing and able to comply with study procedures and complete all scheduled follow-up assessments; Provides written informed consent voluntarily before any study-specific procedure.

Exclusion: Acute myocardial infarction, stroke, intracranial hemorrhage, or unstable angina within 3 months before randomization; Acute limb ischemia or acute exacerbation of chronic limb ischemia within 3 months before randomization; Participation in another interventional clinical study within 30 days before enrollment; Current treatment with immunosuppressive therapy, radiotherapy, or chemotherapy; WIfI foot-infection grade 3, including systemic infection or severe local infection requiring urgent surgical debridement. A potential participant may be reassessed after adequate antimicrobial and surgical management if the infection has improved to WIfI infection grade 1 or 2, systemic infection has resolved, and relevant infection indicators have returned to an acceptable range; New York Heart Association class IV heart failure; Severe hepatic impairment, including decompensated cirrhosis, jaundice, ascites, or variceal bleeding; Active malignant tumor or a history of malignant tumor within 5 years before enrollment. Any broader malignancy-related contraindication in the current seltoplasmid prescribing information will take precedence; Positive human immunodeficiency virus antibody; positive hepatitis C virus antibody; or positive hepatitis B surface antigen together with detectable peripheral-blood hepatitis B virus DNA when, in the investigator's judgment, active chronic hepatitis B may increase participant risk; Any other condition that, in the investigator's judgment and with the reason documented, makes participation inappropriate or exposes the participant to unacceptable risk; Severe renal impairment, defined as serum creatinine >2.5 times the upper limit of normal or estimated glomerular filtration rate <30 mL/min/1.73 m², or current dialysis; Coagulation disorder, defined as platelet count <75 × 10⁹/L or international normalized ratio >1.5 that cannot be corrected; Hemoglobin <80 g/L or white blood cell count <3.0 × 10⁹/L; Poorly controlled diabetes mellitus, defined as glycated hemoglobin >10%; Unable or unwilling to undergo lower-extremity arterial revascularization; Gangrene or tissue destruction of the target limb for which above-ankle major amputation is considered immediately necessary or unavoidable; Any contraindication to seltoplasmid injection according to the current prescribing information; Alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal; Pregnant or breastfeeding woman, or woman of childbearing potential unwilling to use effective contraception during the protocol-defined period. Pregnancy testing and contraceptive requirements will follow the protocol and current prescribing information; Life expectancy <12 months or, in the investigator's judgment, inability to complete follow-up; Any serious comorbidity that may interfere with assessment of study outcomes, or any psychological or social circumstance that may materially prevent optimal participation in the study, in the investigator's judgment.

ClinicalTrials.gov NCT07827521