SIMCARE MEDICAL RESEARCH

Non-Healing Diabetic Foot Ulcer and Venous Leg Ulcer

Study Protocol

Assessing the Efficacy of Human Placental Membrane Products and Standard of Care versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

Study Duration

24 MONTHS

INCLUSION CRITERIA

  • ≥18 years old
  • Type 1 or 2 diabetes
  • Target ulcer:
  • On plantar foot, ≥50% below malleolus
  • Wagner Grade 1–2
  • Present ≥4 weeks
  • Size 1.0–15.0 cm²
  • Adequate vascular perfusion
  • If multiple ulcers, ≥2 cm apart
  • Offloaded for 14 days before enrollment and agrees to continue offloading
  • HbA1c <12% (past 3 months)
  • Agrees to weekly study visits