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

Kuros Biosurgery AG34 sites in 6 countries211 target enrollmentMay 2009

ConditionsDiabetic Foot Ulcer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Kuros Biosurgery AG
Enrollment: 211
Locations: 34
Primary Endpoint: Percentage reduction in ulcer surface area
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

March 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kuros Biosurgery AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•male or female, aged ≥ 18 years
•given written informed consent
•female of childbearing potential with a negative result from the pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial
•Type 1 or Type 2 Diabetes mellitus with HbA1c =\< 12%
•with only one diabetic foot ulcer on the foot to be treated on or below the ankle

Exclusion Criteria

•pregnant or breast-feeding
•known or suspected allergies to any of the components of the I-020201
•uncontrolled anemia (Hb \< 9 g/dL in females and \< 10 g/dL in males)
•hypoalbuminemia (albumin \< 3 g/dL)
•overtly infected target ulcer (as judged by investigator)
•highly exuding wounds (wounds that require a daily dressing change)
•osteomyelitis
•systemic infections
•acute Charcot foot and severe chronic Charcot deformity
•ABPI \< 0.7 or ankle systolic pressure \< 70 mm Hg

Outcomes

Primary Outcomes

Percentage reduction in ulcer surface area

Time Frame: 4 weeks after treatment start

Secondary Outcomes

Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)(Within the whole study period (28 weeks after treatment start))
Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).(At any time during the study)
Incidence of treatment failure defined as <30% decrease in ulcer size(After 8 weeks of treatment)
Incidence of patients with ulcer recurrence(Up to 16 and 28 weeks after treatment start)
Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs(During the whole study period)
Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin(At 1, 4, 12, 16 and 20 weeks after treatment start)
Changes in vital signs, body weight, physical examination and laboratory parameters(Throughout the study and 28 weeks after treatment start)