AM for Refractory Achilles Tendinopathy

NCT06172218 | Completed

• 1 other identifier: 2023-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from Baseline in NRS score

  over 3 months

• Change from Baseline in VISA-A score

  over 3 months

• Proportion of responders based on change in VISA-A score

  over 3 months

• Proportion of complete pain relief

  over 3 months

• Time to complete pain relief

  over 3 months

Study Arms (2)

Micronized Amniotic Membrane

EXPERIMENTAL

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

Other: Flo; Other: Saline

Preservative Free Normal Saline

PLACEBO COMPARATOR

2.0 mL sterile, preservative free 0.9% NaCl

Other: Saline

Interventions

Flo OTHER

sterile, micronized human amniotic membrane product derived from placenta and umbilical cord

Micronized Amniotic Membrane

Saline OTHER

sterile, preservative free 0.9% NaCl

Micronized Amniotic Membrane; Preservative Free Normal Saline

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Planned surgical procedure below knee of the targeted extremity during study period
• Patient has previously received an injection for this injury within the past 2 months
• Major lower limb amputation of the contralateral leg
• A medical condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
• Osteoarthritis, chronic low back pain, fibromyalgia or any other condition that may affect the responses on the VISA-A
• HIV infection, Hepatitis B or C infection, tuberculosis, COVID-19, cellulitis or any other active infection
• Cognitive impairment, mental illness, neuroses, or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures
• Peritendinopathy, paratenonitis, partial tear or tendon rupture of the affected tendon
• Subject has hindfoot deformities on the targeted extremity
• 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
• Leg length discrepancy, hyperpronation, varus deformity of the forefoot, pes cavus or limited mobility of the subtalar joint
• Prior surgical intervention to the affected tendon
• Current use of vitamins or herbal supplements
• Current use of opioids, midazolam, gabapentin, pregabalin or ketamine
• Compensable disability or work injury, ongoing litigation, or ongoing chiropractic care

Sponsors & Collaborators

• North Park Podiatry: lead

Study Sites (1)

North Park Podiatry

San Diego, California, 92104, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Podiatrist/ Founder

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: November 22, 2023
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)