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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00915486
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
Kuros Biosurgery AG

Tracking Information
First Submitted Date  ICMJE June 5, 2009
First Posted Date  ICMJE June 8, 2009
Last Update Posted Date March 16, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
Percentage reduction in ulcer surface area [ Time Frame: 4 weeks after treatment start ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
  • Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) [ Time Frame: 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) ]
  • Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards). [ Time Frame: At any time during the study ]
  • Incidence of treatment failure defined as <30% decrease in ulcer size [ Time Frame: After 8 weeks of treatment ]
  • Incidence of patients with ulcer recurrence [ Time Frame: 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 ]
  • 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 ]
  • Changes in vital signs, body weight, physical examination and laboratory parameters [ Time Frame: Throughout the study and 28 weeks after treatment start ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE
  • Procedure: Good Standard of Care (GSoC)
    Procedural treatment twice per week
  • Biological: Vehicle
    Topical fibrin as an adjunct to GSoC twice per week
  • Biological: I-020201
    Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week
Study Arms  ICMJE
  • Experimental: Good Standard of Care (GSoC)
    Twice per week
    Intervention: Procedure: Good Standard of Care (GSoC)
  • Experimental: GSoC + vehicle
    Twice per week
    Interventions:
    • Procedure: Good Standard of Care (GSoC)
    • Biological: Vehicle
  • Experimental: GSoC + I-020201 (33microg)
    Twice per week
    Interventions:
    • Procedure: Good Standard of Care (GSoC)
    • Biological: I-020201
  • Experimental: GSoC + I-020201 (100microg)
    Twice per week
    Interventions:
    • Procedure: Good Standard of Care (GSoC)
    • Biological: I-020201
  • Experimental: GSoC + I-020201 (300microg)
    Twice per week
    Interventions:
    • Procedure: Good Standard of Care (GSoC)
    • Biological: I-020201
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2011)
211
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2009)
210
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Hungary,   Romania,   Russian Federation,   Serbia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00915486
Other Study ID Numbers  ICMJE CS I-020201/01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kuros Biosurgery AG
Study Sponsor  ICMJE Kuros Biosurgery AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Virginia Jamieson, MD Kuros Biosurgery
PRS Account Kuros Biosurgery AG
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP