AM for Refractory Achilles Tendinopathy

Launched by NORTH PARK PODIATRY · Dec 7, 2023

Keywords

ClinConnect Summary

The clinical trial titled "AM for Refractory Achilles Tendinopathy" is looking at a new treatment option for people suffering from a painful condition called Achilles tendinopathy, which can occur at the back of the ankle. This trial is specifically for individuals whose symptoms have not improved with standard treatments, like physical therapy. The researchers want to see if using a special type of tissue called micronized amniotic membrane can help repair or support the damaged area in patients with this chronic condition.

To be eligible for the trial, participants need to be between 18 and 64 years old and have been diagnosed with Achilles tendinopathy for at least three months. They should have attempted physical therapy that included specific exercises for at least six weeks and have a certain level of pain measured by a score called VISA-A. Participants will receive either the new treatment or standard care and will be asked to follow up regularly to share their experiences and results. It’s a great opportunity for those looking for relief after exhausting other options, but there are certain health conditions and recent treatments that may prevent someone from joining the study.

Gender

ALL

Eligibility criteria

• 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