search
Back to results

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)

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Good Standard of Care (GSoC)
Vehicle
I-020201
Sponsored by
Kuros Biosurgery AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic, ulcer, topical, PDGF, GSoC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)
  • Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)
  • Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)
  • Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23)
  • Klinikum Sindelfingen-Böblingen (01)
  • SRH Klinikum Karlsbad-Langensteinbach (04)
  • Klinikum Stuttgart Bürgerhospital (03)
  • Universitätsklinik Tübingen Chirugische Poliklinik (02)
  • Budai Irgalmasrendi Közhasznú Non-Profit Kft (35)
  • Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32)
  • Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33)
  • Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34)
  • Kaposi Mór Oktató Kórház (38)
  • Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31)
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30)
  • PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36)
  • SZTE Szent-Györgyi Albert Klinikai Centrum (37)
  • Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42)
  • Spitalul Clinic Judeţean de Urgenţă Cluj (43)
  • Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)
  • Cabinet Medical Individual DermaMed (41)
  • Spitalul Clinic Judetean de Urgenta Timisoara (45)
  • Moscow City Clinical Hospital # 13 (11)
  • Moscow State University of Public Health "City Clinical (17)
  • Department of Endocrinology and Diabetes, Russian State Medical University, Moscow City Clinical Hospital # 1 (15)
  • Department of Diabetic Foot Endocrinology dispensary (12)
  • Endocrinology Clinic of the State Educational Institute of High Professional Education (18)
  • Federal State Institution "Federal Bureau of Medical Social Expertise" (10)
  • Moscow Clinical Hospital # 81 (14)
  • Klinički centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51)
  • Clinical Centre Kragujevac (54)
  • Clinical Centre Nis (50)
  • Clinical Centre of Vojvodina (53)
  • Health Centre Valjevo (52)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Good Standard of Care (GSoC)

GSoC + vehicle

GSoC + I-020201 (33microg)

GSoC + I-020201 (100microg)

GSoC + I-020201 (300microg)

Arm Description

Twice per week

Twice per week

Twice per week

Twice per week

Twice per week

Outcomes

Primary Outcome Measures

Percentage reduction in ulcer surface area

Secondary Outcome Measures

Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).
Incidence of treatment failure defined as <30% decrease in ulcer size
Incidence of patients with ulcer recurrence
Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs
Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin
Changes in vital signs, body weight, physical examination and laboratory parameters

Full Information

First Posted
June 5, 2009
Last Updated
March 15, 2012
Sponsor
Kuros Biosurgery AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00915486
Brief Title
A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers
Acronym
DFU
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuros Biosurgery AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic, ulcer, topical, PDGF, GSoC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Good Standard of Care (GSoC)
Arm Type
Experimental
Arm Description
Twice per week
Arm Title
GSoC + vehicle
Arm Type
Experimental
Arm Description
Twice per week
Arm Title
GSoC + I-020201 (33microg)
Arm Type
Experimental
Arm Description
Twice per week
Arm Title
GSoC + I-020201 (100microg)
Arm Type
Experimental
Arm Description
Twice per week
Arm Title
GSoC + I-020201 (300microg)
Arm Type
Experimental
Arm Description
Twice per week
Intervention Type
Procedure
Intervention Name(s)
Good Standard of Care (GSoC)
Intervention Description
Procedural treatment twice per week
Intervention Type
Biological
Intervention Name(s)
Vehicle
Intervention Description
Topical fibrin as an adjunct to GSoC twice per week
Intervention Type
Biological
Intervention Name(s)
I-020201
Intervention Description
Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week
Primary Outcome Measure Information:
Title
Percentage reduction in ulcer surface area
Time Frame
4 weeks after treatment start
Secondary Outcome Measure Information:
Title
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Time Frame
At 12 and 16 weeks after treatment start
Title
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)
Title
Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).
Time Frame
At any time during the study
Title
Incidence of treatment failure defined as <30% decrease in ulcer size
Time Frame
After 8 weeks of treatment
Title
Incidence of patients with ulcer recurrence
Time Frame
Up to 16 and 28 weeks after treatment start
Title
Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs
Time Frame
During the whole study period
Title
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
Title
Changes in vital signs, body weight, physical examination and laboratory parameters
Time Frame
Throughout the study and 28 weeks after treatment start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Jamieson, MD
Organizational Affiliation
Kuros Biosurgery
Official's Role
Study Director
Facility Information:
Facility Name
Diabetologické centrum, I. Interní klinika FN Hradec Králové, Fakultní nemocnice Hradec Králové (21)
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Interní klinika 2. Lékařské fakulty UK a FN Motol, Fakultní nemocnice Motol (22)
City
Praha
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Lékařský dum Ormiga Angiologická a diabetologická ambulance (20)
City
Zlín
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Oddelení diabetologie - Podiatricka ambulance Krajská zdravotní a.s.- Masarykova nemocnice v Ústí nad Labem o.z. (23)
City
Ústí nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Klinikum Sindelfingen-Böblingen (01)
City
Böblingen
ZIP/Postal Code
71031
Country
Germany
Facility Name
SRH Klinikum Karlsbad-Langensteinbach (04)
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany
Facility Name
Klinikum Stuttgart Bürgerhospital (03)
City
Stuttgart
ZIP/Postal Code
70191
Country
Germany
Facility Name
Universitätsklinik Tübingen Chirugische Poliklinik (02)
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Budai Irgalmasrendi Közhasznú Non-Profit Kft (35)
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Fõvárosi Önkormányzat Egyesített Szent István és Szent László Kórház - Rendelõintézet Sebészeti Osztály (32)
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Fővárosi Önkormányzat Szent Imre Kórház Operativ Szakmák Mátrix Szervezete Általános Sebészeti Profil (33)
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Esztergom Város Önkormányzat Vaszary Kolos Kórház Sebészeti Osztály (34)
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Kaposi Mór Oktató Kórház (38)
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bács-Kiskun Megyei Önkormányzat Kórháza Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, 2. Belgyógyászat (31)
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Érsebészeti Osztály (30)
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
PTE Klinikai Központ Érsebészeti Klinikai Tanszék (36)
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
SZTE Szent-Györgyi Albert Klinikai Centrum (37)
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Institutul Naţional de Diabet, Nutriţie şi Boli Metabolice "Prof. Dr. N. C. Paulescu" (42)
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic Judeţean de Urgenţă Cluj (43)
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic Judeţean Mureş, Clinica de Dermatologie (40)
City
Tg Mures
ZIP/Postal Code
540342
Country
Romania
Facility Name
Cabinet Medical Individual DermaMed (41)
City
Tg. Mures,
ZIP/Postal Code
540530
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Timisoara (45)
City
Timisoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
Moscow City Clinical Hospital # 13 (11)
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Moscow State University of Public Health "City Clinical (17)
City
Moscow
ZIP/Postal Code
115432
Country
Russian Federation
Facility Name
Department of Endocrinology and Diabetes, Russian State Medical University, Moscow City Clinical Hospital # 1 (15)
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
Department of Diabetic Foot Endocrinology dispensary (12)
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Endocrinology Clinic of the State Educational Institute of High Professional Education (18)
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Federal State Institution "Federal Bureau of Medical Social Expertise" (10)
City
Moscow
ZIP/Postal Code
123448
Country
Russian Federation
Facility Name
Moscow Clinical Hospital # 81 (14)
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Klinički centar Srbije, Institut za endokrinologiju, dijabetes i bolesti metabolizma (51)
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Clinical Centre Kragujevac (54)
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Facility Name
Clinical Centre Nis (50)
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical Centre of Vojvodina (53)
City
Novi Sad
ZIP/Postal Code
21 000
Country
Serbia
Facility Name
Health Centre Valjevo (52)
City
Valjevo
ZIP/Postal Code
14 000
Country
Serbia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs