AM for Refractory Achilles Tendinopathy

North Park Podiatry

Status: Enrolling

Conditions: Achilles Tendinopathy

Treatments: Other: Flo; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06172218

2023-001

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 to 64 years old
2. BMI ≤ 40 kg/m2
3. Subject has been diagnosed with unilateral Achilles tendinopathy (based on investigator assessment using ultrasound) of at least 3 months duration
4. 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
5. VISA-A score for the target tendon ≥40 and ≤60 at screening
6. Subject is willing to comply with all study procedures
7. Willing to sign a written informed consent to participate
8. Able to follow study instructions, with the intention of completing all required visits

Exclusion criteria

1. Planned surgical procedure below knee of the targeted extremity during study period
2. Patient has previously received an injection for this injury within the past 2 months
3. Major lower limb amputation of the contralateral leg
4. A medical condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
5. Osteoarthritis, chronic low back pain, fibromyalgia or any other condition that may affect the responses on the VISA-A
6. HIV infection, Hepatitis B or C infection, tuberculosis, COVID-19, cellulitis or any other active infection
7. Cognitive impairment, mental illness, neuroses, or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures
8. Peritendinopathy, paratenonitis, partial tear or tendon rupture of the affected tendon
9. Subject has hindfoot deformities on the targeted extremity
10. 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
11. Leg length discrepancy, hyperpronation, varus deformity of the forefoot, pes cavus or limited mobility of the subtalar joint
12. Prior surgical intervention to the affected tendon
13. Current use of vitamins or herbal supplements
14. Current use of opioids, midazolam, gabapentin, pregabalin or ketamine
15. Compensable disability or work injury, ongoing litigation, or ongoing chiropractic care
16. Current use of systemic immunosuppressive medications, chemotherapy, or history of organ transplant (kidney, heart, lung)
17. Pregnancy and women who are expecting to be pregnant
18. Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Micronized Amniotic Membrane

Experimental group

Description:

Injection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl

Treatment:

Other: Flo

Other: Saline

Preservative Free Normal Saline

Placebo Comparator group

Description:

2.0 mL sterile, preservative free 0.9% NaCl

Treatment:

Other: Saline