AM for Refractory Achilles Tendinopathy

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Controlled Pilot Study Assessing Micronized Amniotic Membrane and Umbilical Cord Particulate in Patients With Symptomatic and Refractory Achilles Tendinopathy

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Other: Flo
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micronized Amniotic Membrane<br>Injection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl | Other: Flo<br>* sterile, micronized human amniotic membrane product derived from placenta and umbilical cord<br>Other: Saline<br>* sterile, preservative free 0.9% NaCl<br>|
| Placebo Comparator: Preservative Free Normal Saline<br>2.0 mL sterile, preservative free 0.9% NaCl | Other: Saline<br>* sterile, preservative free 0.9% NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Achilles pain | A score of 0 is considered no pain while a score of 10 is considered very severe pain | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in NRS score | A score of 0 is considered no pain while a score of 10 is considered very severe pain | over 3 months | 
| Change from Baseline in VISA-A score |  | over 3 months | 
| Proportion of responders based on change in VISA-A score | 20 points as a threshold for assignment of responder status | over 3 months | 
| Proportion of complete pain relief | pain score of 0 | over 3 months | 
| Time to complete pain relief | pain score of 0 | over 3 months | 
| Proportion of subjects that respond feeling at least better and satisfied | patient satisfaction survey | 3 months |