Micronized amniotic membrane treatment for chronic Achilles tendinopathy

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

This study tests if a new treatment using micronized amniotic membrane can help people with chronic Achilles tendinopathy who haven't improved with regular therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: North Park Podiatry (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06172218 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of micronized amniotic membrane as a treatment for patients suffering from chronic insertional or non-insertional Achilles tendinopathy that has not responded to standard care. Participants will be divided into treatment and control groups to assess outcomes, with the aim of informing a larger multi-center study in the future. The study focuses on patients who have undergone at least six weeks of physical therapy without sufficient improvement.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 64 with unilateral Achilles tendinopathy lasting at least three months and a VISA-A score between 40 and 60.

Not a fit: Patients who have had recent injections for their injury or are planning surgery on the affected limb during the study period may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with chronic Achilles tendinopathy who have not found relief through conventional therapies.

How similar studies have performed: While this approach is relatively novel, similar studies using regenerative medicine techniques have shown promise in treating other chronic tendon injuries.

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

Where this trial is running

San Diego, California

• North Park Podiatry — San Diego, California, United States (RECRUITING)

Study contacts

• Study coordinator: T Brookshier, DPM

Conditions: Achilles Tendinopathy