Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers

Exclusion Criteria

• •Subjects meeting one or more of the following criteria cannot be selected:
• •1. Anamnesis of current or recent past (within the last 2 years) abuse of alcohol, barbiturates, benzodiazepines, amphetamines, narcotics, cocaine, psychoactive drugs or other abused substances that will interfere with treatment compliance
• •2. Use of growth factors, skin graft or participation in an investigational study within the last 30 days prior to the beginning of the screening period
• •3. Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception or females who test positive on a blood-based pregnancy test
• •4. Have a documented medical history of HIV, HBV or HCV
• •5. Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), metabolic, neurological, hepatic or nephrologic disease and/or receiving dialysis
• •6. Anaemia (Haemoglobin \< 9 gram/dL for females or Haemoglobin \< 10 gram/dL for males) or White Blood Cells count \> 11,000/μL or Platelets count \< 100,000/μL or impaired renal function (Creatinine \> 3 mg/dL) or liver function tests \> 3 times upper normal lab values or any indication of malnourishment (Albumin \< 2.8 g/dL) or any other clinically significant biochemistry, haematology and urinalysis tests;
• •7. Had any clinically significant illness during the last 4 weeks prior to the screening period;
• •8. Have a current malignancy or a past malignancy in the last 5 years other than Basal Cell Carcinoma or is treated by radio/chemotherapy
• •9. Have any signs of clinical infection in the wound (which could be linked to raised body temperature, abscess, osteomyelitis, necrosis or erythema)
• •10. Had any antibiotic treatment during the screening period;
• •11. Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;
• •12. Is bed-ridden or unable to come to the clinic;
• •13. Have more than one target non-healing Diabetic Foot Ulcer per subject;
• •14. Plantar Neuropathic DFU is located on an active Charcot foot;
• •15. Have hind foot ulcer or have a foot deformity/condition preventing the use of offload footwear;
• •16. Had a leg revascularization surgery within the last 6 months or be a candidate for revascularization surgery during the course of the study;
• •17. Glucocorticosteroid treatment (Prednisone \>10 mg/day or its equivalent)
• •18. Inability to stop alternative wound healing treatment (e.g. Becaplermin or other topical products) following debridement