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

Diabetic Foot Ulcer Clinical Trial

— DFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915486
• Other study ID #: CS I-020201/01
• 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

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

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