The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers

Summary

* Diabetic foot ulcers (DFU) are one of the chronic consequences of diabetes which constitute the most important cause of non-traumatic amputation of the inferior limbs. Patients with diabetes are 22 times more likely to have foot ulceration or gangrene than nondiabetics，while foot ulceration precedes 85% of lower-extremity amputation. * Three factors combine to promote tissue necrosis in diabetic feet: ischemia, neuropathy and trauma. Among them, ischemia peripheral arterial disease may play the important roles in the development of DFU. Moreover, diffuse vascular disease is the main characteristics, and thus it becomes difficult for treatment by using arterial bypass or balloon angioplasty. Therefore, we hypothesized that continuous arterial thrombolysis may be an effective therapy in diabetic foot. The purpose of this study is to investigate the effectiveness and safety of continuous intra-femoral artery injection of urokinase by micro-artery-pump in diabetic ulcers.

Timeline

Start

2010-05

Primary completion

2022-12-30

Completion

2022-12-30

Outcome

Met primary endpoint

paper ulcer closure rate, continuous intrafemoral thrombolysis therapy obtained a better complete healing rate (HR 3.42 (95% CI 2.35 to 4.98, p<0.0001)). PMID 38216296 ↗

Publications

• Tong J, Zhang J, Xiang L, Li S, Xu J, Zhu G, Dong J, Cheng Y, Ren H, Liu M, Yue L, Xiang G. Continuous intrafemoral artery infusion of urokinase improves diabetic foot ulcers healing and decreases cardiovascular events in a long-term follow-up study. BMJ Open Diabetes Res Care. 2024 Jan 12;12(1):e003414. doi: 10.1136/bmjdrc-2023-003414.

Drugs

Indications