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

NCT01108120 | Completed Phase 2 DMC

• 1 other identifier: q9jhrvf3-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetic Foot Ulcer

Keywords

diabetic foot ulcer; artery mini-pump; continuous infusion of urokinase; femoral artery

Outcome Measures

Primary Outcomes (2)

• healing rate of diabetic foot ulcers

  During hospitalization, the healing rate of foot ulcers is observed.

  < 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.

  8 years

Secondary Outcomes (1)

• cardiovascular events during the follow up period

  8 years

Study Arms (2)

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.

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.

Drug: Conventional therapy group

Interventions

continuous intra-femoral thrombolysis group DRUG

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.

continuous intra-femoral thrombolysis group

Conventional therapy group DRUG

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

conventional therapy group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetic foot ulcer
• \< = 80 years old
• diabetic foot ulcer wegnar 2-4 stage

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiang Guang-da: lead

Study Sites (1)

The General Hospital of Central theater Command

Wuhan, Hubei, 430070, China

Location

Related Publications (1)

• 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.

  PMID: 38216296 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endocrinol Dept.

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 21, 2010
• Study Start: May 1, 2010
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)