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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuros Biosurgery AG
ClinicalTrials.gov Identifier:
NCT00915486
First received: June 5, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcer
Procedure: Good Standard of Care (GSoC)
Biological: Vehicle
Biological: I-020201
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Kuros Biosurgery AG:

Primary Outcome Measures:
  • Percentage reduction in ulcer surface area [ Time Frame: 4 weeks after treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) [ Time Frame: At 12 and 16 weeks after treatment start ] [ Designated as safety issue: No ]
  • Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) [ Time Frame: Within the whole study period (28 weeks after treatment start) ] [ Designated as safety issue: No ]
  • Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards). [ Time Frame: At any time during the study ] [ Designated as safety issue: No ]
  • Incidence of treatment failure defined as <30% decrease in ulcer size [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Incidence of patients with ulcer recurrence [ Time Frame: Up to 16 and 28 weeks after treatment start ] [ Designated as safety issue: No ]
  • Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs [ Time Frame: During the whole study period ] [ Designated as safety issue: No ]
  • Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin [ Time Frame: At 1, 4, 12, 16 and 20 weeks after treatment start ] [ Designated as safety issue: No ]
  • Changes in vital signs, body weight, physical examination and laboratory parameters [ Time Frame: Throughout the study and 28 weeks after treatment start ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: May 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Good Standard of Care (GSoC)
Twice per week
Procedure: Good Standard of Care (GSoC)
Procedural treatment twice per week
Experimental: GSoC + vehicle
Twice per week
Procedure: Good Standard of Care (GSoC)
Procedural treatment twice per week
Biological: Vehicle
Topical fibrin as an adjunct to GSoC twice per week
Experimental: GSoC + I-020201 (33microg)
Twice per week
Procedure: Good Standard of Care (GSoC)
Procedural treatment twice per week
Biological: I-020201
Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week
Experimental: GSoC + I-020201 (100microg)
Twice per week
Procedure: Good Standard of Care (GSoC)
Procedural treatment twice per week
Biological: I-020201
Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week
Experimental: GSoC + I-020201 (300microg)
Twice per week
Procedure: Good Standard of Care (GSoC)
Procedural treatment twice per week
Biological: I-020201
Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915486

Locations
Czech Republic
Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)
Hradec Králové, Czech Republic, 500 05
Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)
Praha, Czech Republic, 150 06
Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)
Zlín, Czech Republic, 760 01
Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23)
Ústí nad Labem, Czech Republic, 401 13
Germany
Klinikum Sindelfingen-Böblingen (01)
Böblingen, Germany, 71031
SRH Klinikum Karlsbad-Langensteinbach (04)
Karlsbad, Germany, 76307
Klinikum Stuttgart Bürgerhospital (03)
Stuttgart, Germany, 70191
Universitätsklinik Tübingen Chirugische Poliklinik (02)
Tübingen, Germany, 72076
Hungary
Budai Irgalmasrendi Közhasznú Non-Profit Kft (35)
Budapest, Hungary, 1027
Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33)
Budapest, Hungary, 1115
Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32)
Budapest, Hungary, 1097
Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34)
Esztergom, Hungary, 2500
Kaposi Mór Oktató Kórház (38)
Kaposvar, Hungary, 7400
Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31)
Kecskemét, Hungary, 6000
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30)
Miskolc, Hungary, 3526
PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36)
Pécs, Hungary, 7623
SZTE Szent-Györgyi Albert Klinikai Centrum (37)
Szeged, Hungary, 6720
Romania
Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42)
Bucharest, Romania, 020475
Spitalul Clinic Judeţean de Urgenţă Cluj (43)
Cluj-Napoca, Romania, 400006
Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)
Tg Mures, Romania, 540342
Cabinet Medical Individual DermaMed (41)
Tg. Mures,, Romania, 540530
Spitalul Clinic Judetean de Urgenta Timisoara (45)
Timisoara, Romania, 300723
Russian Federation
Federal State Institution "Federal Bureau of Medical Social Expertise" (10)
Moscow, Russian Federation, 123448
Moscow City Clinical Hospital # 13 (11)
Moscow, Russian Federation, 115280
Department of Diabetic Foot Endocrinology dispensary (12)
Moscow, Russian Federation, 119034
Moscow State University of Public Health "City Clinical (17)
Moscow, Russian Federation, 115432
Endocrinology Clinic of the State Educational Institute of High Professional Education (18)
Moscow, Russian Federation, 119992
Department of Endocrinology and Diabetes, Russian State Medical University, Moscow City Clinical Hospital # 1 (15)
Moscow, Russian Federation, 117049
Moscow Clinical Hospital # 81 (14)
Moscow, Russian Federation, 127644
Serbia
Klinički centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51)
Belgrade, Serbia, 11 000
Clinical Centre Kragujevac (54)
Kragujevac, Serbia, 34 000
Clinical Centre Nis (50)
Nis, Serbia, 18000
Clinical Centre of Vojvodina (53)
Novi Sad, Serbia, 21 000
Health Centre Valjevo (52)
Valjevo, Serbia, 14 000
Sponsors and Collaborators
Kuros Biosurgery AG
Investigators
Study Director: Virginia Jamieson, MD Kuros Biosurgery
  More Information

No publications provided

Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT00915486     History of Changes
Other Study ID Numbers: CS I-020201/01
Study First Received: June 5, 2009
Last Updated: March 15, 2012
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Kuros Biosurgery AG:
Diabetic
ulcer
topical
PDGF
GSoC

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014