NCT00915486

A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers

A Randomized, Multi-center, Controlled, Parallel Group, Dose Finding Study of the Efficacy and Safety of Topically Applied I-020201 as an Adjunct to Good Standard-of-care Versus Good Standard-of-care Alone in Patients With Chronic Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Kuros Biosurgery AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population ages. The large population affected by diabetic foot ulcers and the high rates of failure ending with amputation even with the best therapeutic regimens have resulted in the development of new therapies. I-020201 is a bioactive therapy intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the granulation tissue formation. This study aims to evaluate the safety and efficacy of I-020201 in adjunct to good standard of care in patients with chronic diabetic foot ulcer.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
PROCEDURE	Good Standard of Care (GSoC)	Procedural treatment twice per week
BIOLOGICAL	Vehicle	Topical fibrin as an adjunct to GSoC twice per week
BIOLOGICAL	I-020201	Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-06-08
• Last updated: 2012-03-16

Locations

34 sites across 6 countries: Czechia, Germany, Hungary, Romania, Russia, Serbia