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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2010 by Wuhan General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01108120
First received: April 19, 2010
Last updated: July 4, 2013
Last verified: April 2010
  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.

Condition Intervention Phase
Diabetic Foot Ulcer
Drug: continuous intra-femoral thrombolysis group
Drug: Conventional therapy group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Wuhan General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • healing rate of diabetic foot ulcers [ Time Frame: < half a year ] [ Designated as safety issue: Yes ]
    During hospitalization, the healing rate of foot ulcers is observed.

  • The recurrence rate of diabetic foot ulcers [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
    During the 8 years of follow up period, recurrence rate of diabetic foot ulcers are observed at 1, 4, 8 year.


Secondary Outcome Measures:
  • cardiovascular events during the follow up period [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
    During the follow up period of 8 years, the cardiovascular events, death from all causes are observed at 1, 4 and 8 year.


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: continuous intra-femoral thrombolysis group
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.
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.
Experimental: conventional therapy group
Conventional therapy group receives an intravenous injection of prostaglandin E1 20 ug per day. The follow up was taken for 8 years.
Drug: Conventional therapy group
All patients receive an intravenous injection of prostaglandin E1 20 ug per day during hospitalization period.

Detailed Description:
  • We select 200 diabetic patients with Wagner grade 1 ~ 3 foot ulcers. They are divided into two groups randomly: thrombolysis group and control group, 100 cases in each group.
  • After diabetic dietary advice, all patients receive insulin therapy to control blood glucose within a range of 5 - 10 mmol/L. Then the patients receive conventional care for their ulcers. To remove extensive callus and necrotic tissue, wound debridement was performed. Broad spectrum antibiotics are prescribed if ulcers show clinical signs of infection. Adjustments to the treatment are performed when indicated on the basis of microbiologic cultures and sensitivity testing.
  • The conventional group patients receive an intravenous injection of prostaglandin E1 (20 ug per day)until the healing of ulcers or discharged from hospital. In the continuous intra-femoral thrombolysis group, first of all, a ultrasound Doppler examination of vessels including artery and venous of lower limbs were performed. To avoid pulmonary infarction, a filtrator is placed in the inferior vena cava before the thrombolysis process if ultrasound results show venous thrombosis. Then insert a percutaneous artery canal from femoral artery in another lower limb into the distal of popliteal artery as far as possible. After finishing this process, the outside part of this artery canal is fixed at thigh, and the patients must keep in supine position in the bed.Firstly,20 0000 ~ 40 0000 units urokinase is injected via the catheter to diseased foot. Then, continuous infusion urokinase via femoral artery by an artery pump (100 ml 0.9% sodium chloride + 100 0000 unit urokinase at a rate of 4 ml per one hour) for 7 - 10 days. Finally, patients receive an intravenous injection of prostaglandin E1 (20 ug per day)until the healing of ulcers or discharged from hospital.
  • The healing rate of foot ulcers, the time of ulcers, neuropathy symptoms, the period of hospitalization are compared between the two groups during hospitalization.
  • The recurrence rate of foot ulcers, cardiovascular events, death from all causes are compared between two groups at 1, 4, 8 years during follow up.
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108120

Contacts
Contact: Xiang Guangda, MD, Ph D +862768878410 Guangda64@hotmail.com

Locations
China, Hubei
Recruiting
Wuhan City, Hubei, China, 43000
Contact: Xiang Guangda, MD, Ph D    +862768878410    Guangda64@hotmail.com   
Sponsors and Collaborators
Xiang Guang-da
  More Information

No publications provided

Responsible Party: Xiang Guang-da, Director of Endocrinol Dept., Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01108120     History of Changes
Other Study ID Numbers: q9jhrvf3-2
Study First Received: April 19, 2010
Last Updated: July 4, 2013
Health Authority: China: Ethics Committee

Keywords provided by Wuhan General Hospital of Guangzhou Military Command:
diabetic foot ulcer
artery mini-pump
continuous infusion of urokinase
femoral artery

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Alprostadil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014