drugset / Trial / NCT01108120

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

NCT01108120

Phase 2 Completed 200 enrolled Xiang Guang-da
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Urokinase Protein / enzyme biologic 1e+06 iu Other
Comparator Misoprostol Other / unclassified 20 ug Intravenous

Indications