Diabetic patients with elevated HbA1c values, elevated NLR values and DFU Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
The drug WF10 will be applied via intravenous infusion by using a dose of 0.3 ml/kg body weight (BW). Thereby the appropriate drug amount will always be diluted in 300 ml physiological saline for an i
Sponsors
OXO Translational Science GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients, at least 18 years of age, maximum age 80 years 2. Body mass index (BMI) <35 kg/m² 3. Diabetes mellitus type 2, diagnosed since at least 1 year and presently treated with standard care for at least 3 months prior to enrolment 4. Patients with active diabetic foot problems, according to the diabetic foot stratification table, starting at least 3 weeks prior to enrolment or infected wound degree 3 – 4 5. HbA1c =8.0 % (63.9 mmol/mol) 6. NLR: 3 – 35 7. No or mild anemia (Hct =27 %, Hb =9.0 g/dl) 8. No blood transfusion within the last 2 months before screening 9. eGFR = 30 – 89 ml/min/1.73 m² BSA (Grades 2 – 3b) 10. Urinary microalbumin excretion <300 mg/l 11. Urine Albumin-Creatinine Ratio (uACR) =300 mg/g (Categories A1 – A2) 12. Having good vein access 13. Willing and able to adhere to the study regulations including attendance to the scheduled visits to the trial site 14. Willing and able to provide informed consent Inclusion criteria for females: 1. Women of Childbearing Potential (WOCBP) presently on standard of care with hormonal treatment (including hormonal contraception) for at least 3 months prior to enrollment 2. WOCBP who are not on contraception shall be advised on Barrier Protection or Copper Intrauterine Device (IUD)
Exclusion criteria
Exclusion criteria: 1. Previous participation in any clinical trial within the last 3 months before screening 2. Previous treatment with WF10 within the last 4 months 3. Karnofski performance status 3x upper limit of normality 7.2. Serum K+ >6.0 or <3.0 mEq/l Exclusion criteria for females: 1. Pregnant or lactating 2. NOT surgically sterile 3. NOT taking medically adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c measured using blood sample at Screen, baseline, week 4, week 6, week 8, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Routine clinical laboratory safety tests (fasting morning) at Screen, baseline, week 4, week 6, week 8, week 12: 1.1. Hematology: RBC, hemoglobin (Hb), haematocrit (HCT), red cell distribution width (RDW), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), reticulocyte (RTC), platelet (PLT), white blood cell (WBC) (absolute and differential), calculated NLR 1.2. Coagulation: prothrombin time (PT, international normalized ratio [INR]), activated partial thromboplastin time (aPTT) 1.3. Routine clinical chemistry: aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl transpeptidase (gGT), alkaline phosphatase, lactate dehydrogenase (LDH), total and direct bilirubin, creatinine, urea, uric acid, glucose, total protein, albumin, triglycerides, total cholesterol, sodium, potassium, calcium, chloride, phosphorus, bicarbonate; calculated estimated glomerular filtration rate (eGFR) 1.4. Semi-quantitative urinalysis (Dip-Stick): microalbumin excretion 1.5. Quantitative (spot sample): albumin-creatinine, sodium-creatinine and cystatin C-creatinine ratio (UCCR) 2. Full blood picture with complete blood count (see above) and microscopic evaluation and interpretation of the blood cell morphology at baseline, week 4, week 6, week 8, and week 12. During the microscopic blood cell evaluation, photographic images of the blood smears shall be taken for electronic documentation. 3. Blood pressure and pulse rate measured by means of an automated oscillometric device at Screen, baseline, week 1, week 2, week 3, week 4, week 6, week 8, week 12 4. 12-lead ECG (rhythm, PQ, QRS, QT, QTc, clinical diagnosis/evaluation) at Screen, (Baseline), and week 12 5. AGE determination using blood and urine samples at Screen, baseline, week2, week 4, week 8 | — |
Countries
Malaysia
Outcome results
None listed