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)

Kuros Biosciences

Status and phase: Completed; Phase 2

Conditions: Diabetic Foot Ulcer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00915486

CS I-020201/01

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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211 participants in 5 patient groups

Good Standard of Care (GSoC)

Experimental group

Description:

Twice per week

Treatment:

Procedure: Good Standard of Care (GSoC)

GSoC + vehicle

Experimental group

Description:

Twice per week

Treatment:

Biological: Vehicle

Procedure: Good Standard of Care (GSoC)

GSoC + I-020201 (33microg)

Experimental group

Description:

Twice per week

Treatment:

Biological: I-020201

Procedure: Good Standard of Care (GSoC)

GSoC + I-020201 (100microg)

Experimental group

Description:

Twice per week

Treatment:

Biological: I-020201

Procedure: Good Standard of Care (GSoC)

GSoC + I-020201 (300microg)

Experimental group

Description:

Twice per week

Treatment:

Biological: I-020201

Procedure: Good Standard of Care (GSoC)