Treatment of diabetic foot ulcer MedDRA version: 20.0 Level: LLT Classification code 10012684 Term: Diabetic peripheral vascular disease System Organ Class: 100000004866
Conditions
Interventions
Product Name: BAY 1193397 1 mg immediate release (IR) tablets
Product Code: BAY 1193397 1 mg immediate release (IR) tablets
Pharmaceutical Form: Tablet
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The informed consent must be signed before any study specific tests or procedures are done (patient must be able to give informed consent, no legal representative allowed) - Patients with a diagnosis of type II diabetes mellitus and PAD and/or microangiopathy as evidenced by at least one of the following criteria: a) TBPI 40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification). Male patients, who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for 12 weeks after receiving the investigational medicinal product and not to act as sperm donor for 12 weeks after dosing. Acceptable methods of contraception include for example: a) condoms (male or female) with or without a spermicidal agent b) diaphragm or cervical cap with spermicide c) intrauterine device d) hormone-based contraception - Ability to understand and follow study related instructions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: Medical and surgical history - Patients with existing lower limb ulcers - Patients with nailfold capillaries at the great toe that are technically difficult to assess - Patients suffering from PAD Fontaine Stage 4 - Patients requiring planned revascularization - Patients suffering from diseases other than diabetes mellitus that are known to lead to disturbances in skin microcirculation or interfering with the method of measurement such as Raynaud’s disease, collagen vascular disorders , atopic dermatitis, psoriasis - Patients with diabetes mellitus induced by immunosuppressive treatment - Patients with renal replacement therapy - Patients with organ transplants - Medical history of autoimmune disease - Myocardial infarction, acute coronary syndrome, transient ischemic attack (TIA), stroke, revascularization, angioplasty within 3 months prior to randomization - Any planned surgical intervention during the course of the study - Medical condition or history thereof or any deviation from normal laboratory values that in the opinion of the investigator would impair the ability to complete the planned study procedures - Any surgical or medical condition which significantly alters absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal (GI) tract surgery, inflammatory bowel disease, currently active gastritis, pancreatitis, treatment with cholestyramine and colestipol resins - Patients with HbA1c > 12% (> 108 mmol/mol) at the screening visit - Any other condition or therapy, which would make the subject unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months) Medication, drug use and special behavioral patterns - Use of alpha or beta AR agonists - Use of alpha AR antagonists - Use of serotonin/norepinephrine reuptake inhibitors (SNRIs) - Use of tricyclic antidepressants at a dose equivalent of more than 50 mg amitryptyline - Use of strong CYP 3A4 inhibitors (as specified in the study protocol) within 7 days prior to first administration and until follow-up. Topical use of antifungal cream is allowed. - Use of strong CYP 3A4 inducers (as specified in the study protocol) within 7 days prior to first administration and until follow up Consumption of grapefruit (juice or fruit) within 7 days prior to first administration and until follow-up - Use of St John´s wort within 7 days prior to first administration and until follow-up - Suspicion of drug or alcohol abuse - Donation of more than 100 / 500 mL of blood within 4 weeks / 3 months prior to screening - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) - No pedicure or nail polish is allowed from screening until the end of the active study period (end of treatment period 3) ECG, blood pressure, heart rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the changes in resting blood flow speed in skin capillaries before and after study drug administration. Investigate the change in peak capillary blood flow speed during a temporary increase in blood flow (reactive hyperemia) before and after study drug administration. Investigate the change in time to peak capillary blood flow speed during a temporary increase in blood flow (reactive hyperemia) before and after study drug administration. Investigate the change in oxygen pressure through the skin before and after study drug administration ;Secondary Objective: Analyse the safety and tolerability of BAY 1193397 after a single dose administration as evidenced by the incidence and severity of adverse events; Primary end point(s): Change in resting CBV (capillary blood flow velocity) (= resting CBV after study drug administration – resting CBV before study drug administration) - Change in peak CBV during reactive hyperemia (= peak CBV after study drug administration – peak CBV before study drug administration) - Change in time to peak CBV during reactive hyperemia (= time to peak CBV after study drug administration – time to peak CBV before study drug administration) - Change in foot TcPO2 (transcutaneous oxygen pressure) (= TcPO2 after study drug administration – TcPO2 before study drug administration) ;Timepoint(s) of evaluation of this end point: 1 hour after administration of study drug at visits 2,3,4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence and severity of adverse events;Timepoint(s) of evaluation of this end point: After administration of study drug at visits 2,3,4 | — |
Countries
United Kingdom
Contacts
Public ContactEarly Clinical Lead (ECL)
Bayer AG
Outcome results
None listed