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

NCT ID: NCT00915486

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-03-31

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Good Standard of Care (GSoC)

Twice per week

Group Type: EXPERIMENTAL

Good Standard of Care (GSoC)

Intervention Type: PROCEDURE

Procedural treatment twice per week

GSoC + vehicle

Twice per week

Group Type: EXPERIMENTAL

Good Standard of Care (GSoC)

Intervention Type: PROCEDURE

Procedural treatment twice per week

Vehicle

Intervention Type: BIOLOGICAL

Topical fibrin as an adjunct to GSoC twice per week

GSoC + I-020201 (33microg)

Twice per week

Group Type: EXPERIMENTAL

Good Standard of Care (GSoC)

Intervention Type: PROCEDURE

Procedural treatment twice per week

I-020201

Intervention Type: BIOLOGICAL

Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

GSoC + I-020201 (100microg)

Twice per week

Group Type: EXPERIMENTAL

Good Standard of Care (GSoC)

Intervention Type: PROCEDURE

Procedural treatment twice per week

I-020201

Intervention Type: BIOLOGICAL

Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

GSoC + I-020201 (300microg)

Twice per week

Group Type: EXPERIMENTAL

Good Standard of Care (GSoC)

Intervention Type: PROCEDURE

Procedural treatment twice per week

I-020201

Intervention Type: BIOLOGICAL

Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

Interventions

Good Standard of Care (GSoC)

Procedural treatment twice per week

Intervention Type: PROCEDURE

Vehicle

Topical fibrin as an adjunct to GSoC twice per week

Intervention Type: BIOLOGICAL

I-020201

Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

Intervention Type: BIOLOGICAL

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuros Biosurgery AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia Jamieson, MD

Role: STUDY_DIRECTOR

Kuros Biosurgery

Locations

Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)

Hradec Králové, , Czechia

Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)

Prague, , Czechia

Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23)

Ústí nad Labem, , Czechia

Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)

Zlín, , Czechia

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, , Germany

Budai Irgalmasrendi Közhasznú Non-Profit Kft (35)

Budapest, , Hungary

Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32)

Budapest, , Hungary

Fővárosi 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)

Kaposvár, , 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, , Hungary

Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42)

Bucharest, , Romania

Spitalul Clinic Judeţean de Urgenţă Cluj (43)

Cluj-Napoca, , Romania

Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)

Tg Mures, , Romania

Cabinet Medical Individual DermaMed (41)

Tg. Mures,, , Romania

Spitalul Clinic Judetean de Urgenta Timisoara (45)

Timișoara, , Romania

Moscow City Clinical Hospital # 13 (11)

Moscow, , Russia

Moscow State University of Public Health "City Clinical (17)

Moscow, , Russia

Department of Endocrinology and Diabetes, Russian State Medical University, Moscow City Clinical Hospital # 1 (15)

Moscow, , Russia

Department of Diabetic Foot Endocrinology dispensary (12)

Moscow, , Russia

Endocrinology Clinic of the State Educational Institute of High Professional Education (18)

Moscow, , Russia

Federal State Institution "Federal Bureau of Medical Social Expertise" (10)

Moscow, , Russia

Moscow Clinical Hospital # 81 (14)

Moscow, , Russia

Klinički centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51)

Belgrade, , Serbia

Clinical Centre Kragujevac (54)

Kragujevac, , Serbia

Clinical Centre Nis (50)

Niš, , Serbia

Clinical Centre of Vojvodina (53)

Novi Sad, , Serbia

Health Centre Valjevo (52)

Valjevo, , Serbia

Countries

Czechia; Germany; Hungary; Romania; Russia; Serbia

Other Identifiers

CS I-020201/01

Identifier Type: -

Identifier Source: org_study_id