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The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers
This study is currently Recruiting
April 2010 By Wuhan General Hospital of Guangzhou Military Command
First Recieved on April 19, 2010
Last Updated on April 20, 2010
- 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.
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|continuous intra-femoral thrombolysis group:Experimental|
Continuous intra-femoral injection urokinase was taken by a mini-pump in 100 diabetic foot ulcers (Wegnar 2 ~ 4 stage) for 7 - 9 days.Then they receive conventional therapy. The healing rate of foot ulcers is observed during hospitalization period. At 1, 4 and 8 year during follow up, the recurrence rate of diabetic foot ulcers are observed.
|conventional therapy group:Experimental|
Conventional therapy group receives an intravenous injection of prostaglandin E1 20 ug per day. The follow up was taken for 8 years.
|Drug:continuous intra-femoral thrombolysis group|
Firstly, 20 0000 u urokinase is injected to the diseased foot via catheter. Then, continuous injection of urokinase via femoral artery by a artery mini-pump (100 ml 0.9% sodium chloride + 100 0000 unit urokinase at a rate of 4 ml per hour) is taken for 7 - 9 days.
|Drug:Conventional therapy group|
All patients receive an intravenous injection of prostaglandin E1 20 ug per day during hospitalization period.
|Ages Eligible for Study:||30 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||Accepts Healthy Volunteers|
- diabetic foot ulcer
- < = 80 years old
- diabetic foot ulcer wegnar 2-4 stage
- Wagner grade 0,1 and grade 5
- severe coronary, cerebral, renal vascular as well as severe liver diseases, malignant
- bleeding individuals
- > 80 years old
- heart failure (NYHA 3,4)