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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Procedure: Good Standard of Care (GSoC)
* Biological: Vehicle
* Biological: I-020201


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Good Standard of Care (GSoC)<br>Twice per week | Procedure: Good Standard of Care (GSoC)<br>* Procedural treatment twice per week<br>|
| Experimental: GSoC + vehicle<br>Twice per week | Procedure: Good Standard of Care (GSoC)<br>* Procedural treatment twice per week<br>Biological: Vehicle<br>* Topical fibrin as an adjunct to GSoC twice per week<br>|
| Experimental: GSoC + I-020201 (33microg)<br>Twice per week | Procedure: Good Standard of Care (GSoC)<br>* Procedural treatment twice per week<br>Biological: I-020201<br>* Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week<br>|
| Experimental: GSoC + I-020201 (100microg)<br>Twice per week | Procedure: Good Standard of Care (GSoC)<br>* Procedural treatment twice per week<br>Biological: I-020201<br>* Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week<br>|
| Experimental: GSoC + I-020201 (300microg)<br>Twice per week | Procedure: Good Standard of Care (GSoC)<br>* Procedural treatment twice per week<br>Biological: I-020201<br>* Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in ulcer surface area |  | 4 weeks after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) |  | At 12 and 16 weeks after treatment start | 
| Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards) |  | Within the whole study period (28 weeks after treatment start) | 
| 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 treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs |  | During the whole study period | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic, ulcer, topical, PDGF, GSoC