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

NCT00915486 | Completed Phase 2 DMC

• 1 other identifier: CS I-020201/01
• Study Type: interventional
• Target: 211
• Locations: 6 countries
• Sites: 34

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

Keywords

Diabetic; ulcer; topical; PDGF; GSoC

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in ulcer surface area

  4 weeks after treatment start

Secondary Outcomes (8)

• Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)

  At 12 and 16 weeks after treatment start

• 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

Study Arms (5)

Good Standard of Care (GSoC)

EXPERIMENTAL

Twice per week

Procedure: Good Standard of Care (GSoC)

GSoC + vehicle

EXPERIMENTAL

Twice per week

Procedure: Good Standard of Care (GSoC); Biological: Vehicle

GSoC + I-020201 (33microg)

EXPERIMENTAL

Twice per week

Procedure: Good Standard of Care (GSoC); Biological: I-020201

GSoC + I-020201 (100microg)

EXPERIMENTAL

Twice per week

Procedure: Good Standard of Care (GSoC); Biological: I-020201

GSoC + I-020201 (300microg)

EXPERIMENTAL

Twice per week

Procedure: Good Standard of Care (GSoC); Biological: I-020201

Interventions

Good Standard of Care (GSoC) PROCEDURE

Procedural treatment twice per week

GSoC + I-020201 (100microg); GSoC + I-020201 (300microg); GSoC + I-020201 (33microg); GSoC + vehicle; Good Standard of Care (GSoC)

Vehicle BIOLOGICAL

Topical fibrin as an adjunct to GSoC twice per week

GSoC + vehicle

I-020201 BIOLOGICAL

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

GSoC + I-020201 (100microg); GSoC + I-020201 (300microg); GSoC + I-020201 (33microg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuros Biosurgery AG: lead

Study Sites (34)

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

Hradec Králové, 500 05, Czechia

Location

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

Prague, 150 06, Czechia

Location

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

Ústí nad Labem, 401 13, Czechia

Location

Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)

Zlín, 760 01, Czechia

Location

Klinikum Sindelfingen-Böblingen (01)

Böblingen, 71031, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach (04)

Karlsbad, 76307, Germany

Location

Klinikum Stuttgart Bürgerhospital (03)

Stuttgart, 70191, Germany

Location

Universitätsklinik Tübingen Chirugische Poliklinik (02)

Tübingen, 72076, Germany

Location

Budai Irgalmasrendi Közhasznú Non-Profit Kft (35)

Budapest, 1027, Hungary

Location

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

Budapest, 1097, Hungary

Location

Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33)

Budapest, 1115, Hungary

Location

Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34)

Esztergom, 2500, Hungary

Location

Kaposi Mór Oktató Kórház (38)

Kaposvár, 7400, Hungary

Location

Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31)

Kecskemét, 6000, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30)

Miskolc, 3526, Hungary

Location

PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36)

Pécs, 7623, Hungary

Location

SZTE Szent-Györgyi Albert Klinikai Centrum (37)

Szeged, 6720, Hungary

Location

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

Bucharest, 020475, Romania

Location

Spitalul Clinic Judeţean de Urgenţă Cluj (43)

Cluj-Napoca, 400006, Romania

Location

Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)

Tg Mures, 540342, Romania

Location

Cabinet Medical Individual DermaMed (41)

Tg. Mures,, 540530, Romania

Location

Spitalul Clinic Judetean de Urgenta Timisoara (45)

Timișoara, 300723, Romania

Location

Moscow City Clinical Hospital # 13 (11)

Moscow, 115280, Russia

Location

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

Moscow, 115432, Russia

Location

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

Moscow, 117049, Russia

Location

Department of Diabetic Foot Endocrinology dispensary (12)

Moscow, 119034, Russia

Location

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

Moscow, 119992, Russia

Location

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

Moscow, 123448, Russia

Location

Moscow Clinical Hospital # 81 (14)

Moscow, 127644, Russia

Location

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

Belgrade, 11 000, Serbia

Location

Clinical Centre Kragujevac (54)

Kragujevac, 34 000, Serbia

Location

Clinical Centre Nis (50)

Niš, 18000, Serbia

Location

Clinical Centre of Vojvodina (53)

Novi Sad, 21 000, Serbia

Location

Health Centre Valjevo (52)

Valjevo, 14 000, Serbia

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Virginia Jamieson, MD

  Kuros Biosurgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

RO (5); HU (9); CZ (4); DE (4); RU (7); SE (5)