Safety and Efficacy of a Novel Topical Formulation Containing Erythropoietin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02361931
Recruitment Status : Recruiting
First Posted : February 12, 2015
Last Update Posted : April 12, 2016
Information provided by (Responsible Party):
Remedor Biomed Ltd

Brief Summary:
The investigative product, developed by Remedor, is a unique gel formulation that optimizes the administration of EPO to the wound bed. This novel formulation has been shown to stabilize EPO in the gel and to maintain its activity over long periods.

Condition or disease Intervention/treatment Phase
Diabetic Chronic Ulcers Drug: A formula with erythropoietin Drug: Hydrogel Phase 2

Detailed Description:

Erythropoietin (EPO) has been shown to play a major role in wound healing. EPO is a safe molecule, and commercially available biomolecule which is the basis of an FDA approved drug for treating anemia. EPO has a known mechanism of action on chronic wounds that affects all phases of the wound healing process and has shown promising results in experimental animal wound models [Hamed et al., 2010, 2011]. In humans, topically applied EPO considerably enhanced wound healing and improved wound conditions of acute and chronic wounds [Bader et al., 2011]. Our study seeks to extend these findings, to investigate the efficacy of EPO for treatment of diabetic chronic wounds in humans.

The investigative product, developed by Remedor, is a unique gel formulation that optimizes the administration of EPO to the wound bed. This novel formulation has been shown to stabilize EPO in the gel and to maintain its activity over long periods.

The Remedor formulation used in the clinical trials will be prepared either by a compounding pharmacy which is approved by the Israeli Ministry of Health, or by an Israeli GMP certified pharmaceutical plant.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Study Start Date : April 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment group (erythropoietin)
15 patients will receive erythropoietin (3000IU/ml) containing formula. Topically, five days a week for 12 weeks.
Drug: A formula with erythropoietin
Active Comparator: Standard Care group
5 patients will receive Hydrogel. Daily for three months.
Drug: Hydrogel

Primary Outcome Measures :
  1. No Safety issues compared to Std treatment [ Time Frame: 4 months ]

    The wound will be treated either with the investigational formulation or the conventional treatment daily for 3 months.. After 15 minutes, the wound will be dressed with a fresh TegadermTM dressing. Monitoring of any adverse events will be performed on a daily basis.

    Once a week, the wound will be monitored by a physician: wound size will be determined and documented by photograph. Patients will be evaluated for pain sensation at the wound area and satisfaction by completing a QoL questionnaire Once a month during the experiment and one month after the end of treatment patients will undergo blood profile, blood glucose, and urine samples testing: at the initial and terminating visits. ECG and Ulcer culture will be also carried out. HbA1c, will be monitored once in 4 months

  2. Complete closure of the wound [ Time Frame: up to 6 months ]
    Same as above

Secondary Outcome Measures :
  1. Accelerated healing (time to healing and improvement compared to baseline) [ Time Frame: 7 months ]
    Same as above

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 cm2 ≤ Wound area at start of treatment ≤ 10 cm2;
  5. At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) 0.4 <ABI < 0.9 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;

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02361931

Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Rinat Lasker    +972503312506   
Sponsors and Collaborators
Remedor Biomed Ltd
Study Chair: Yehuda Ullman, Professor Rambam Health Care Campus

Responsible Party: Remedor Biomed Ltd Identifier: NCT02361931     History of Changes
Other Study ID Numbers: 0252-12-RMB
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Keywords provided by Remedor Biomed Ltd:
accelerating healing
diabetic chronic wounds
diabetic patients
diabetic chronic ulcers
Wagner grade II
mild drainage

Additional relevant MeSH terms:
Pathologic Processes
Epoetin Alfa