NCT01108120

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

Completed Phase 2 Last updated 26 September 2023

What this trial tests

Phase 2 trial testing continuous intra-femoral thrombolysis group in Diabetic Foot Ulcer in 200 participants. Completed in 30 December 2022.

Timeline

1 May 2010

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Xiang Guang-da
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 May 2010
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across China

Drugs / interventions tested

• continuous intra-femoral thrombolysis group — full drug profile →
• Conventional therapy group

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

Xiang Guang-da — full company profile →

Who can join

Adults 30 to 80, any sex, with Diabetic Foot Ulcer. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcriptomics-driven drug repositioning for the treatment of diabetic foot ulcer.
   Adikusuma W, Zakaria ZA, Irham LM, Nopitasari BL, et al · · 2023 · cited 6× · PMID 37340026 · DOI 10.1038/s41598-023-37120-1
2. Continuous intrafemoral artery infusion of urokinase improves diabetic foot ulcers healing and decreases cardiovascular events in a long-term follow-up study.
   Tong J, Zhang J, Xiang L, Li S, et al · · 2024 · PMID 38216296 · DOI 10.1136/bmjdrc-2023-003414