AM for Refractory Achilles Tendinopathy

Completed · Not applicable

Conditions studied: Achilles Tendinopathy

In brief

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.

Key facts

Study ID

NCT06172218

Run by

North Park Podiatry

People needed

20

Starts

2023-11-22

Expected to finish

2026-01-20

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Subject has hindfoot deformities on the targeted extremity
• Plantar fasciitis, calcaneal bursitis, Sever's disease, retrocalcaneal exostosis (Mulholland deformity, Haglund's deformity), enthesophytes, myofascial pain referral, posterior ankle impingement, os trigonum syndrome, tenosynovitis or dislocation of the peroneal or other plantar flexor tendons, an accessory soleus muscle, irritation or neuroma of the sural nerve, or systemic inflammatory disease
• Leg length discrepancy, hyperpronation, varus deformity of the forefoot, pes cavus or limited mobility of the subtalar joint
• Prior surgical intervention to the affected tendon
• Current use of vitamins or herbal supplements
• Current use of opioids, midazolam, gabapentin, pregabalin or ketamine
• Compensable disability or work injury, ongoing litigation, or ongoing chiropractic care
• Current use of systemic immunosuppressive medications, chemotherapy, or history of organ transplant (kidney, heart, lung)
• Pregnancy and women who are expecting to be pregnant
• Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study

Where it is running

• North Park Podiatry — San Diego, California, United States

Full record on ClinicalTrials.gov

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