AM for Refractory Achilles Tendinopathy

Last updated: December 7, 2023
Sponsor: North Park Podiatry
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sprains

Tendon Injuries

Treatment

Flo

Saline

Clinical Study ID

NCT06172218
2023-001
  • Ages 18-64
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 to 64 years old
  2. BMI ≤ 40 kg/m2
  3. Subject has been diagnosed with unilateral Achilles tendinopathy (based oninvestigator assessment using ultrasound) of at least 3 months duration
  4. History of having attempted a physical therapy for Achilles tendinopathy which musthave included at least 6 weeks of eccentric exercise, alone or in addition to othernon-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 requiredvisits

Exclusion

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'sopinion, is not appropriate for participation in the trial
  5. Osteoarthritis, chronic low back pain, fibromyalgia or any other condition that mayaffect the responses on the VISA-A
  6. HIV infection, Hepatitis B or C infection, tuberculosis, COVID-19, cellulitis or anyother active infection
  7. Cognitive impairment, mental illness, neuroses, or untreated depression that wouldpreclude 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 theperoneal or other plantar flexor tendons, an accessory soleus muscle, irritation orneuroma of the sural nerve, or systemic inflammatory disease
  11. Leg length discrepancy, hyperpronation, varus deformity of the forefoot, pes cavus orlimited 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 chiropracticcare
  16. Current use of systemic immunosuppressive medications, chemotherapy, or history oforgan 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 insuch a study within 30 days of anticipated entry into this study

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Flo
Phase:
Study Start date:
November 22, 2023
Estimated Completion Date:
June 28, 2024

Connect with a study center

  • North Park Podiatry

    San Diego, California 92104
    United States

    Active - Recruiting

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