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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

Sponsor: Wuhan General Hospital of Guangzhou Military Command
Collaborators:
Information provided by: Wuhan General Hospital of Guangzhou Military Command
Identifier: NCT01108120

Purpose

- 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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:30 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - diabetic foot ulcer - < = 80 years old - diabetic foot ulcer wegnar 2-4 stage Exclusion Criteria: - Wagner grade 0,1 and grade 5 - severe coronary, cerebral, renal vascular as well as severe liver diseases, malignant neoplasms - bleeding individuals - > 80 years old - heart failure (NYHA 3,4) - cancer

Investigators

Locations

  • Wuhan City, Hubei 43000 China

Conditions related to this trial:

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