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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)

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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

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Procedure: Good Standard of Care (GSoC) Biological: Vehicle Biological: I-020201 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage reduction in ulcer surface area [ Time Frame: 4 weeks after treatment start ]

Secondary Outcome Measures :
  1. Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) [ Time Frame: At 12 and 16 weeks after treatment start ]
  2. 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) ]
  3. Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards). [ Time Frame: At any time during the study ]
  4. Incidence of treatment failure defined as <30% decrease in ulcer size [ Time Frame: After 8 weeks of treatment ]
  5. Incidence of patients with ulcer recurrence [ Time Frame: Up to 16 and 28 weeks after treatment start ]
  6. Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs [ Time Frame: During the whole study period ]
  7. 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 ]
  8. Changes in vital signs, body weight, physical examination and laboratory parameters [ Time Frame: Throughout the study and 28 weeks after treatment start ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915486


Locations
Show Show 34 study locations
Sponsors and Collaborators
Kuros Biosurgery AG
Investigators
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Study Director: Virginia Jamieson, MD Kuros Biosurgery
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Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT00915486    
Other Study ID Numbers: CS I-020201/01
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012
Keywords provided by Kuros Biosurgery AG:
Diabetic
ulcer
topical
PDGF
GSoC
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases