RegeneRx

Am I Eligible?

Eligibility:

Inclusion Criteria:

  • Ages eligible for the study: between 18 and 79 years of age.
  • Both genders are eligible for the study.
  • Informed Consent Form signed by the patient or patient's legal representative.
  • At least one venous leg ulceration (index ulcer used for study assessments).
  • Surface area between 3 and 30 cm2 active ulcer.
  • Index ulcer stable for at least 6 weeks before enrollment.

Exclusion Criteria:

  • Have the designated ulcer below the malleolus, on the foot, or above the base of the knee.
  • Have clinical evidence of active infection on the index ulcer.
  • Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment.
  • Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment.
  • History of adverse events to any ingredients of study medication.
  • Current or former malignancy.
  • Arterial or venous disorder resulting in ulcerated wounds.
  • Diabetes mellitus.
  • Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)