Clinical trial NCT00915486: A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic
ulcer
topical
PDGF
GSoC
Lead sponsor: Kuros Biosurgery AG
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage reduction in ulcer surface area
timeFrame: 4 weeks after treatment start
Secondary outcomes:
measure: Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
timeFrame: At 12 and 16 weeks after treatment start
measure: Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
timeFrame: Within the whole study period (28 weeks after treatment start)
measure: Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).
timeFrame: At any time during the study
measure: Incidence of treatment failure defined as <30% decrease in ulcer size
timeFrame: After 8 weeks of treatment
measure: Incidence of patients with ulcer recurrence
timeFrame: Up to 16 and 28 weeks after treatment start
measure: Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs
timeFrame: During the whole study period
measure: Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin
timeFrame: At 1, 4, 12, 16 and 20 weeks after treatment start
measure: Changes in vital signs, body weight, physical examination and laboratory parameters
timeFrame: Throughout the study and 28 weeks after treatment start
Other outcomes:
Locations:
city: Hradec Králové
country: Czech Republic
facility: Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)
city: Praha
country: Czech Republic
facility: Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)
city: Zlín
country: Czech Republic
facility: Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)
city: Ústí nad Labem
country: Czech Republic
facility: Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23)
city: Böblingen
country: Germany
facility: Klinikum Sindelfingen-Böblingen (01)
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach (04)
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Bürgerhospital (03)
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen Chirugische Poliklinik (02)
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Közhasznú Non-Profit Kft (35)
city: Budapest
country: Hungary
facility: Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32)
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33)
city: Esztergom
country: Hungary
facility: Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34)
city: Kaposvar
country: Hungary
facility: Kaposi Mór Oktató Kórház (38)
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31)
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30)
city: Pécs
country: Hungary
facility: PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36)
city: Szeged
country: Hungary
facility: SZTE Szent-Györgyi Albert Klinikai Centrum (37)
city: Bucharest
country: Romania
facility: Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42)
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judeţean de Urgenţă Cluj (43)
city: Tg Mures
country: Romania
facility: Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)
city: Tg. Mures,
country: Romania
facility: Cabinet Medical Individual DermaMed (41)
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara (45)
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital # 13 (11)
city: Moscow
country: Russian Federation
facility: Moscow State University of Public Health "City Clinical (17)
city: Moscow
country: Russian Federation
facility: Department of Endocrinology and Diabetes, Russian State Medical University, Moscow City Clinical Hospital # 1 (15)
city: Moscow
country: Russian Federation
facility: Department of Diabetic Foot Endocrinology dispensary (12)
city: Moscow
country: Russian Federation
facility: Endocrinology Clinic of the State Educational Institute of High Professional Education (18)
city: Moscow
country: Russian Federation
facility: Federal State Institution "Federal Bureau of Medical Social Expertise" (10)
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital # 81 (14)
city: Belgrade
country: Serbia
facility: Klinički centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51)
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac (54)
city: Nis
country: Serbia
facility: Clinical Centre Nis (50)
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina (53)
city: Valjevo
country: Serbia
facility: Health Centre Valjevo (52)
Study officials:
affiliation: Kuros Biosurgery
name: Virginia Jamieson, MD
role: STUDY_DIRECTOR
References: