drugset / Trial / 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

NCT00915486 ↗

Phase 2 Completed 211 enrolled Kuros Biosurgery AG
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-05
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject I-020201 Unknown 33 ug Topical
Subject I-020201 Unknown 100 ug Topical
Subject I-020201 Unknown 300 ug Topical

Indications