AM for Refractory Achilles Tendinopathy (NCT06172218) | Clinical Trial Compass
CompletedNot Applicable
AM for Refractory Achilles Tendinopathy
United States20 participantsStarted 2023-11-22
Plain-language summary
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.
Who can participate
Age range18 Years – 64 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Planned surgical procedure below knee of the targeted extremity during study period
✕. Patient has previously received an injection for this injury within the past 2 months
✕. Major lower limb amputation of the contralateral leg
✕. A medical condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
. Osteoarthritis, chronic low back pain, fibromyalgia or any other condition that may affect the responses on the VISA-A
✕. HIV infection, Hepatitis B or C infection, tuberculosis, COVID-19, cellulitis or any other active infection
✕. Cognitive impairment, mental illness, neuroses, or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures
✕. Peritendinopathy, paratenonitis, partial tear or tendon rupture of the affected tendon