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

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: Good Standard of Care (GSoC); Biological: Vehicle; Biological: I-020201

• Registration Number: NCT00915486
• Lead Sponsor: Kuros Biosurgery AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Good Standard of Care (GSoC)	Good Standard of Care (GSoC)	Twice per week
GSoC + vehicle	Good Standard of Care (GSoC)	Twice per week
GSoC + vehicle	Vehicle	Twice per week
GSoC + I-020201 (33microg)	Good Standard of Care (GSoC)	Twice per week
GSoC + I-020201 (33microg)	I-020201	Twice per week
GSoC + I-020201 (100microg)	Good Standard of Care (GSoC)	Twice per week
GSoC + I-020201 (100microg)	I-020201	Twice per week
GSoC + I-020201 (300microg)	Good Standard of Care (GSoC)	Twice per week
GSoC + I-020201 (300microg)	I-020201	Twice per week

Primary Outcome Measures

Name	Time	Method
Percentage reduction in ulcer surface area	4 weeks after treatment start

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (34)

SRH Klinikum Karlsbad-Langensteinbach (04); 🇩🇪 Karlsbad, Germany

Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42); 🇷🇴 Bucharest, Romania

Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22); 🇨🇿 Praha, Czech Republic

Klinikum Sindelfingen-Böblingen (01); 🇩🇪 Böblingen, Germany

Universitätsklinik Tübingen Chirugische Poliklinik (02); 🇩🇪 Tübingen, Germany

Lékařský dum Ormiga Angiologická a diabetologická ambulance (20); 🇨🇿 Zlín, Czech Republic

Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34); 🇭🇺 Esztergom, Hungary

Kaposi Mór Oktató Kórház (38); 🇭🇺 Kaposvar, Hungary

Klinikum Stuttgart Bürgerhospital (03); 🇩🇪 Stuttgart, Germany

Budai Irgalmasrendi Közhasznú Non-Profit Kft (35); 🇭🇺 Budapest, Hungary

Klinički centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51); 🇷🇸 Belgrade, Serbia

Clinical Centre Nis (50); 🇷🇸 Nis, Serbia

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30); 🇭🇺 Miskolc, Hungary

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

Moscow City Clinical Hospital # 13 (11); 🇷🇺 Moscow, Russian Federation

Department of Diabetic Foot Endocrinology dispensary (12); 🇷🇺 Moscow, Russian Federation

Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23); 🇨🇿 Ústí nad Labem, Czech Republic

Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31); 🇭🇺 Kecskemét, Hungary

SZTE Szent-Györgyi Albert Klinikai Centrum (37); 🇭🇺 Szeged, Hungary

Cabinet Medical Individual DermaMed (41); 🇷🇴 Tg. Mures,, Romania

Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40); 🇷🇴 Tg Mures, Romania

Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32); 🇭🇺 Budapest, Hungary

Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21); 🇨🇿 Hradec Králové, Czech Republic

Spitalul Clinic Judeţean de Urgenţă Cluj (43); 🇷🇴 Cluj-Napoca, Romania

Spitalul Clinic Judetean de Urgenta Timisoara (45); 🇷🇴 Timisoara, Romania

Clinical Centre Kragujevac (54); 🇷🇸 Kragujevac, Serbia

Health Centre Valjevo (52); 🇷🇸 Valjevo, Serbia

Moscow State University of Public Health "City Clinical (17); 🇷🇺 Moscow, Russian Federation

PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36); 🇭🇺 Pécs, Hungary

Clinical Centre of Vojvodina (53); 🇷🇸 Novi Sad, Serbia

Federal State Institution "Federal Bureau of Medical Social Expertise" (10); 🇷🇺 Moscow, Russian Federation

Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33); 🇭🇺 Budapest, Hungary

Endocrinology Clinic of the State Educational Institute of High Professional Education (18); 🇷🇺 Moscow, Russian Federation

Moscow Clinical Hospital # 81 (14); 🇷🇺 Moscow, Russian Federation