- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01108120
The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers
September 26, 2023 updated by: Xiang Guang-da
- 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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiang Guangda, MD, Ph D
- Phone Number: +862768878410
- Email: Guangda64@hotmail.com
Study Locations
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Hubei
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Wuhan, Hubei, China, 430070
- The General Hospital of Central theater Command
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Active Comparator: 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.
|
All patients receive an intravenous injection of prostaglandin E1 20 ug per day during hospitalization period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
healing rate of diabetic foot ulcers
Time Frame: < half a year
|
During hospitalization, the healing rate of foot ulcers is observed.
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< half a year
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The recurrence rate of diabetic foot ulcers
Time Frame: 8 years
|
During the 8 years of follow up period, recurrence rate of diabetic foot ulcers are observed at 1, 4, 8 year.
|
8 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiovascular events during the follow up period
Time Frame: 8 years
|
During the follow up period of 8 years, the cardiovascular events, death from all causes are observed at 1, 4 and 8 year.
|
8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
April 19, 2010
First Submitted That Met QC Criteria
April 20, 2010
First Posted (Estimated)
April 21, 2010
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- q9jhrvf3-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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