Diabetic Foot UlcerPhase 2NCT01108120
The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers
A Phase 2 study testing continuous intra-femoral thrombolysis group and Conventional therapy group in people with Diabetic Foot Ulcer, run by Xiang Guang-da at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- continuous intra-femoral thrombolysis group and Conventional therapy group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2010to 30 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetic foot ulcer
- < = 80 years old
- diabetic foot ulcer wegnar 2-4 stage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The General Hospital of Central theater Command
Wuhan, Hubei, 430070
About this study
- 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- continuous intra-femoral thrombolysis group, Conventional therapy group
- Keywords
- diabetic foot ulcer, artery mini-pump, continuous infusion of urokinase, femoral artery
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous intra-femoral thrombolysis groupDrug
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.
Conventional therapy groupDrug
All patients receive an intravenous injection of prostaglandin E1 20 ug per day during hospitalization period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: continuous intra-femoral thrombolysis group |
| conventional therapy group | Active comparator | Conventional therapy group receives an intravenous injection of prostaglandin E1 20 ug per day. The follow up was taken for 8 years. Receives: Drug: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rate of diabetic foot ulcers
During hospitalization, the healing rate of foot ulcers is observed.
Measured: < half a year
The recurrence rate of diabetic foot ulcers
During the 8 years of follow up period, recurrence rate of diabetic foot ulcers are observed at 1, 4, 8 year.
Measured: 8 years
Secondary outcomes (1)
cardiovascular events during the follow up period
During the follow up period of 8 years, the cardiovascular events, death from all causes are observed at 1, 4 and 8 year.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startMay 2010
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiang Guang-da
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108120
- Sponsor's protocol ID
- q9jhrvf3-2
- Status last verified
- Sep 2023
- First submitted
- 19 Apr 2010
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tong J, Zhang J, Xiang L, Li S, Xu J, Zhu G, Dong J, Cheng Y, Ren H, Liu M, Yue L, Xiang G. Continuous intrafemoral artery infusion of urokinase improves diabetic foot ulcers healing and decreases cardiovascular events in a long-term follow-up study. BMJ Open Diabetes Res Care. 2024 Jan 12;12(1):e003414. doi: 10.1136/bmjdrc-2023-003414.
PubMed 38216296
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01108120
- Acronym / sponsor ID
- q9jhrvf3-2
- Conditions
- Diabetic Foot Ulcer
- Keywords
- diabetic foot ulcer, artery mini-pump, continuous infusion of urokinase, femoral artery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Xiang Guang-daUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous intra-femoral thrombolysis group | Experimental | Drug: continuous intra-femoral thrombolysis groupContinuous 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 | Active comparator | Drug: Conventional therapy groupConventional therapy group receives an intravenous injection of prostaglandin E1 20 ug per day. The follow up was taken for 8 years. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetic foot ulcer
- < = 80 years old
- diabetic foot ulcer wegnar 2-4 stage
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous intra-femoral thrombolysis groupFirstly, 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 | continuous intra-femoral thrombolysis group |
| Conventional therapy groupAll patients receive an intravenous injection of prostaglandin E1 20 ug per day during hospitalization period. | Drug | conventional therapy group |
Primary outcome
healing rate of diabetic foot ulcers
Time frame: < half a year
During hospitalization, the healing rate of foot ulcers is observed.
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.
1 secondary outcome
cardiovascular events during the follow up period
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 38216296Tong J, Zhang J, Xiang L, Li S, Xu J, Zhu G, Dong J, Cheng Y, Ren H, Liu M, Yue L, Xiang G. Continuous intrafemoral artery infusion of urokinase improves diabetic foot ulcers healing and decreases cardiovascular events in a long-term follow-up study. BMJ Open Diabetes Res Care. 2024 Jan 12;12(1):e003414. doi: 10.1136/bmjdrc-2023-003414.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing continuous intra-femoral thrombolysis group and Conventional therapy group in people with Diabetic Foot Ulcer, run by Xiang Guang-da at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing rate of diabetic foot ulcers (time frame: < half a year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.