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. 2021 May 6;19(1):144–155. doi: 10.1111/iwj.13606

TABLE 1.

Study inclusion and exclusion criteria

Inclusion criteria
  1. At least 18 years old
  2. Adequate arterial flow indicated by one of the following:
    • Ankle Brachial Pressure Index (ABI) >0.75 and <1.3
    • Skin Perfusion Pressure (SPP) >30
    • Biphasic PVR OR TBI >0.60
    • TCPO2 >30 mmHg
    • Adequate perfusion as demonstrated on florescent angiography (LUNA)
  3. Study ulcer present for at least 12 months
  4. Presence of a venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone
  5. Target ulcer has been treated with adequate compression therapy for at least 7 days prior to enrolment
  6. Ulcer size between 2.0 and 25.0 cm2
  7. Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit
Exclusion criteria
  1. Study ulcer deemed by the investigator to be caused by a medical condition other than venous insufficiency
  2. Study ulcer exhibits clinical signs and symptoms of infection at the screening visit or first treatment visit
  3. Known allergy to the components of the multi‐layer compression bandaging, or cannot tolerate multi‐layer compression therapy
  4. Allergy or sensitivity to iodine or iodide
  5. Study ulcer is suspicious for cancer
  6. Patients with a history of more than 2 weeks treatment with immunosuppressant or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
  7. Study ulcer has been previously treated with tissue engineered materials (eg, Apligraf® or Dermagraft®) or other scaffold materials (eg, Oasis, Matristem) within the last 30 days
  8. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial
  9. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded
  10. Pregnant or breast feeding
  11. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV)
  12. Known uncontrolled Diabetes Mellitus, as measured by an HbA1c >10%
  13. Ulcers that have healed 20% or more during the screening phase
  14. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
  15. History of radiation at the ulcer site
  16. Presence of one or more medical conditions, as determined by medical history, including renal, hepatic, hematologic, active auto‐immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this ulcer healing study