Prospective, Randomized Controlled Pilot Study Assessing Micronized Amniotic Membrane and Umbilical Cord Particulate in Patients With Symptomatic and Refractory Achilles Tendinopathy
To evaluate outcomes after use of micronized amniotic membrane to replace or supplement damaged or inadequate integumental tissue in patients with chronic insertional or non-insertional Achilles tendinopathy that remains refractory to standard care. Outcomes between a control and treatment group in this pilot study will be used to devise a multi-center study with larger sample size.
• Age 18 to 64 years old
• BMI ≤ 40 kg/m2
• Subject has been diagnosed with unilateral Achilles tendinopathy (based on investigator assessment using ultrasound) of at least 3 months duration
• History of having attempted a physical therapy for Achilles tendinopathy which must have included at least 6 weeks of eccentric exercise, alone or in addition to other non-surgical therapies
• VISA-A score for the target tendon ≥40 and ≤60 at screening
• Subject is willing to comply with all study procedures
• Willing to sign a written informed consent to participate
• Able to follow study instructions, with the intention of completing all required visits