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)

March 15, 2012 updated by: Kuros Biosurgery AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
211

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage reduction in ulcer surface area
Time Frame: 4 weeks after treatment start
4 weeks after treatment start

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)
Time Frame: At 12 and 16 weeks after treatment start
At 12 and 16 weeks after treatment start
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)
Within the whole study period (28 weeks after treatment start)
Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).
Time Frame: At any time during the study
At any time during the study
Incidence of treatment failure defined as <30% decrease in ulcer size
Time Frame: After 8 weeks of treatment
After 8 weeks of treatment
Incidence of patients with ulcer recurrence
Time Frame: Up to 16 and 28 weeks after treatment start
Up to 16 and 28 weeks after treatment start
Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs
Time Frame: During the whole study period
During the whole study period
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
At 1, 4, 12, 16 and 20 weeks after treatment start
Changes in vital signs, body weight, physical examination and laboratory parameters
Time Frame: Throughout the study and 28 weeks after treatment start
Throughout the study and 28 weeks after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kuros Biosurgery AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS I-020201/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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