Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers

• Status: Completed
• Trial end date: 2018-06-12
• Target enrollment: 0
• Participant gender: All

Summary

Remedor has developed a patented technology (RMD-G1), which comprises erythropoietin (EPO) as the active pharmaceutical ingredient (API) in a carbopol-based hydrogel with an FN matrix. RMD-G1 was designed to maintain EPO stability and activity over long periods and to optimize the administration of EPO onto the wound bed.

RMD-G1 is indicated for treating DFUs in adult patients with diabetes mellitus and aims to accelerate the healing of diabetic foot ulcers. RMD-G1 is an adjunct treatment, and not a substitute for good diabetic wound care, which includes initial debridement, wound cleansing, pressure relief, and infection control. In this trial, RMD-G1 is applied daily onto a clean wound at 0.25g per sq. cm. wound surface. After its application, the wound will be covered with a dressing in order to prevent leakage of the hydrogel and contamination of the wound area.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Remedor Biomed Ltd
• Treatments: Epoetin Alfa

Criteria

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).