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

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