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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00915486
Other study ID # CS I-020201/01
Secondary ID
Status Completed
Phase Phase 2
First received June 5, 2009
Last updated March 15, 2012
Start date May 2009
Est. completion date March 2012

Study information

Verified date March 2012
Source Kuros Biosurgery AG
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 211
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Good Standard of Care (GSoC)
Procedural treatment twice per week
Biological:
Vehicle
Topical fibrin as an adjunct to GSoC twice per week
I-020201
Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

Locations

Country Name City State
Czech Republic Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21) Hradec Králové
Czech Republic Interní klinika 2. Lékarské fakulty UK a FN Motol, Fakultní nemocnice Motol (22) Praha
Czech Republic Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23) Ústí nad Labem
Czech Republic Lékarský dum Ormiga Angiologická a diabetologická ambulance (20) Zlín
Germany Klinikum Sindelfingen-Böblingen (01) Böblingen
Germany SRH Klinikum Karlsbad-Langensteinbach (04) Karlsbad
Germany Klinikum Stuttgart Bürgerhospital (03) Stuttgart
Germany Universitätsklinik Tübingen Chirugische Poliklinik (02) Tübingen
Hungary Budai Irgalmasrendi Közhasznú Non-Profit Kft (35) Budapest
Hungary Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32) Budapest
Hungary Fovárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33) Budapest
Hungary Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34) Esztergom
Hungary Kaposi Mór Oktató Kórház (38) Kaposvar
Hungary Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31) Kecskemét
Hungary Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30) Miskolc
Hungary PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36) Pécs
Hungary SZTE Szent-Györgyi Albert Klinikai Centrum (37) Szeged
Romania Institutul National de Diabet, Nutritie si Boli Metabolice "Prof. Dr. N. C. Paulescu" (42) Bucharest
Romania Spitalul Clinic Judetean de Urgenta Cluj (43) Cluj-Napoca
Romania Spitalul Clinic Judetean Mures, Clinica de Dermatologie (40) Tg Mures
Romania Cabinet Medical Individual DermaMed (41) Tg. Mures,
Romania Spitalul Clinic Judetean de Urgenta Timisoara (45) Timisoara
Russian Federation Department of Diabetic Foot Endocrinology dispensary (12) Moscow
Russian Federation Department of Endocrinology and Diabetes, Russian State Medical University, Moscow City Clinical Hospital # 1 (15) Moscow
Russian Federation Endocrinology Clinic of the State Educational Institute of High Professional Education (18) Moscow
Russian Federation Federal State Institution "Federal Bureau of Medical Social Expertise" (10) Moscow
Russian Federation Moscow City Clinical Hospital # 13 (11) Moscow
Russian Federation Moscow Clinical Hospital # 81 (14) Moscow
Russian Federation Moscow State University of Public Health "City Clinical (17) Moscow
Serbia Klinicki centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51) Belgrade
Serbia Clinical Centre Kragujevac (54) Kragujevac
Serbia Clinical Centre Nis (50) Nis
Serbia Clinical Centre of Vojvodina (53) Novi Sad
Serbia Health Centre Valjevo (52) Valjevo

Sponsors (1)

Lead Sponsor Collaborator
Kuros Biosurgery AG

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Romania,  Russian Federation,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage reduction in ulcer surface area 4 weeks after treatment start No
Secondary Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) At 12 and 16 weeks after treatment start No
Secondary Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) Within the whole study period (28 weeks after treatment start) No
Secondary Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards). At any time during the study No
Secondary Incidence of treatment failure defined as <30% decrease in ulcer size After 8 weeks of treatment No
Secondary Incidence of patients with ulcer recurrence Up to 16 and 28 weeks after treatment start No
Secondary Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs During the whole study period No
Secondary 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 No
Secondary Changes in vital signs, body weight, physical examination and laboratory parameters Throughout the study and 28 weeks after treatment start No
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