Status:
COMPLETED
A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers
Lead Sponsor:
Kuros Biosurgery AG
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
- one of the following findings (only 1 out of 3 tests is required):
- on Doppler waveform analysis on the dorsalis pedis and posterior tibial arteries a monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or
- a toe: brachial index \< 0.7, or
- transcutaneous oxygen pressure (TcpO2) \< 40 mm Hg
- suspicion, presence or history of systemic or local cancer or tumor of any kind
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00915486
Start Date
May 1 2009
End Date
March 1 2012
Last Update
March 16 2012
Active Locations (34)
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1
Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)
Hradec Králové, Czechia, 500 05
2
Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)
Prague, Czechia, 150 06
3
Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23)
Ústí nad Labem, Czechia, 401 13
4
Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)
Zlín, Czechia, 760 01