Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers

Inclusion Criteria: Patients must satisfy all of the following inclusion criteria to be included in the study: 1. Male or female over the age of 18; 2. Diabetes Mellitus type 2; 3. Have a single non-infected Diabetic Hard-to-Heal wound (ulcers/foot ulcers), Wagner grade I or II documented for at least 4 weeks that has not shown signs of healing despite standard treatment; 4. 2 sq.cm. ≤ Wound area at start of treatment ≤ 10 sq.cm.; 5. At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) of \>0.4 or if ABI \>1.3 then toe pressure \> 50 mmHg; 6. Undergo a current physical examination, which reveals no clinically significant abnormalities, except diabetes or diabetic ulcer/wound related condition; 7. Be available for the entire study period, and be able and willing to adhere to protocol requirements; 8. Provide written informed consent prior to admission into the study; 9. no surgical revascularization of the limb with the DFU was done in the previous two months. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following exclusion criteria: 1. Diabetes Mellitus non Type 2; 2. Have a glycosylated haemoglobin (HbA1c) \>10.0%; 3. Have a body mass index (BMI) \> 40 Kg/m2; 4. Have visible bone exposure at wound site; 5. Subjects whose study ulcer size decreases by more than 30% during this initial standard-of-care phase (pre-treatment phase); 6. Have any signs of infection in the wound (which could be linked to raised body temperature), abscess, cellulitis, necrosis, erythema, mild drainage or known osteomyelitis; 7. Have a history of HIV or a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease; 8. Anemia (Hemoglobin \< 9 g/dL) or White Blood Cells count \> 11,000/μL or Platelets count \< 100,000/μL or liver function tests \> 3 times upper normal lab values or Creatinine \> 3 mg/dL; any indication of malnourishment (Albumin \< 3 g/dL); INR\>2 or any other clinically significant blood and urinalysis tests per the physician's discretion 9. Have any clinically significant chronic or acute illness during the 4 weeks prior to admission into the study, except diabetes type2 or during screening period; 10. Patients on concomitant medications that alter blood glucose levels (e.g. ACE inhibitors, lipid lowering agents, etc.) who have not been on a stable dosage regimen for at least 4 weeks prior to entry into the study and who cannot maintain a stable dosage throughout the study; 11. Malignant disease except Basal Cell Carcinoma or Cervical Carcinoma in situ; Chemotherapy treatment or severely immunosuppressed for any reason that would limit or preclude healing in the opinion of the Investigator; 12. Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years, not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a blood-based pregnancy test; 13. Participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study; 14. Residing in a nursing facility and/or are bed-ridden (unable to come to receive treatment at the clinic).