AM for Refractory Achilles Tendinopathy

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172218
• Other study ID #: 2023-001
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: December 2023
• Source: North Park Podiatry
• Contact: T Brookshier, DPM
• Phone: (619) 283-2097
• Email: trentbrookshier[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 28, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Other:
• Flo
sterile, micronized human amniotic membrane product derived from placenta and umbilical cord
• Saline
sterile, preservative free 0.9% NaCl

Locations

Country	Name	City	State
United States	North Park Podiatry	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
North Park Podiatry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from Baseline in VISA-A score		over 3 months
Secondary	Proportion of responders based on change in VISA-A score	20 points as a threshold for assignment of responder status	over 3 months
Secondary	Proportion of complete pain relief	pain score of 0	over 3 months
Secondary	Time to complete pain relief	pain score of 0	over 3 months
Secondary	Proportion of subjects that respond feeling at least better and satisfied	patient satisfaction survey	3 months