Diabetic Foot Ulcer
Conditions
Keywords
Diabetic, ulcer, topical, PDGF, GSoC
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.
Interventions
PROCEDUREGood Standard of Care (GSoC)
Procedural treatment twice per week
BIOLOGICALVehicle
Topical fibrin as an adjunct to GSoC twice per week
BIOLOGICALI-020201
Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week
Sponsors
Kuros Biosurgery AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in ulcer surface area | 4 weeks after treatment start |
Secondary
| Measure | Time frame |
|---|---|
| Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards). | At any time during the study |
| Incidence of treatment failure defined as <30% decrease in ulcer size | After 8 weeks of treatment |
| Incidence of patients with ulcer recurrence | Up to 16 and 28 weeks after treatment start |
| Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) | At 12 and 16 weeks after treatment start |
| Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin | At 1, 4, 12, 16 and 20 weeks after treatment start |
| Changes in vital signs, body weight, physical examination and laboratory parameters | Throughout the study and 28 weeks after treatment start |
| Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs | During the whole study period |
Countries
Czechia, Germany, Hungary, Romania, Russia, Serbia
Outcome results
None listed