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 range
18 Years – 64 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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