A Dose Finding Study of 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 - Full Text View

Sponsored by:	Kuros Biosurgery AG
Information provided by:	Kuros Biosurgery AG
ClinicalTrials.gov Identifier:	NCT00915486

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

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 ]

Estimated Enrollment:	210
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Good Standard of Care (GSoC): Experimental Twice per week	Procedure: Good Standard of Care (GSoC) Procedural treatment twice per week
GSoC + vehicle: Experimental 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
GSoC + I-020201 (33microg): Experimental 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
GSoC + I-020201 (100microg): Experimental 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
GSoC + I-020201 (300microg): Experimental 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 < 10%
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 < 10 g/dL in females and < 12 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

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

Contacts

Contact: Mitra Safari

+41 44 200 5600 ext 82

mitra.safari@kuros.ch

Locations

Czech Republic
Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)	Not yet recruiting
Zlín, Czech Republic, 760 01
Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)	Not yet recruiting
Hradec Králové, Czech Republic, 500 05
Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)	Not yet recruiting
Praha, Czech Republic, 150 06
Germany
Klinikum Sindelfingen-Böblingen (01)	Not yet recruiting
Böblingen, Germany, 71031
Universitätsklinik Tübingen Chirugische Poliklinik (02)	Not yet recruiting
Tübingen, Germany, 72076
Klinikum Stuttgart Bürgerhospital (03)	Not yet recruiting
Stuttgart, Germany, 70191
Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30)	Recruiting
Miskolc, Hungary, 3526
Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31)	Recruiting
Kecskemét, Hungary, 6000
Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32)	Recruiting
Budapest, Hungary, 1097
Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33)	Recruiting
Budapest, Hungary, 1115
Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34)	Not yet recruiting
Esztergom, Hungary, 2500
Romania
Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)	Not yet recruiting
Tg Mures, Romania, 540342
Cabinet Medical Individual DermaMed (41)	Recruiting
Tg. Mures,, Romania, 540530
Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42)	Recruiting
Bucharest, Romania, 020475
Spitalul Clinic Judeţean de Urgenţă Cluj (43)	Recruiting
Cluj-Napoca, Romania, 400006
Serbia
Clinical Centre Nis (50)	Not yet recruiting
Nis, Serbia, 18000
Clinical Centre of Vojvodina (53)	Not yet recruiting
Novi Sad, Serbia, 21 000
Clinical Centre Kragujevac (54)	Not yet recruiting
Kragujevac, Serbia, 34 000

Sponsors and Collaborators

Kuros Biosurgery AG

More Information

No publications provided

Responsible Party:	Kuros Biosurgery ( Virginia Jamieson )
Study ID Numbers:	CS I-020201/01
Study First Received:	June 5, 2009
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00915486 History of Changes
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 and Social Development of the Russian Federation; Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Kuros Biosurgery AG:

Diabetic
ulcer
topical
PDGF
GSoC

Study placed in the following topic categories:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases

Diabetic Angiopathies
Signs and Symptoms
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases

Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on September 03, 2009