Clinical trial

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

Name

q9jhrvf3-2

Description

* 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.

Trial arms

Trial start

2010-05-01

Estimated PCD

2022-12-30

Trial end

2022-12-30

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

continuous intra-femoral thrombolysis group

Conventional therapy group

All patients receive an intravenous injection of prostaglandin E1 20 ug per day during hospitalization period.

Arms:

conventional therapy group

Size

200

Primary endpoint

healing rate of diabetic foot ulcers

< half a year

The recurrence rate of diabetic foot ulcers

8 years

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}

Updated at

2023-09-28

1 organization

2 products

1 indication

Organization

Xiang Guang-Da

Product

Continuous Intra-Femoral Thrombolysis

Indication

Diabetic Foot Ulcer

Product

Conventional therapy