Achilles TendinopathyNCT06172218
AM for Refractory Achilles Tendinopathy
A study testing Flo and Saline in people with Achilles Tendinopathy, run by North Park Podiatry at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Flo and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2023to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- Current use of systemic immunosuppressive medications, chemotherapy, or history of organ transplant (kidney, heart, lung)
- Pregnancy and women who are expecting to be pregnant
- Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized Controlled Pilot Study Assessing Micronized Amniotic Membrane and Umbilical Cord Particulate in Patients With Symptomatic and Refractory Achilles Tendinopathy
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
- Being tested
- Flo, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloOther
sterile, micronized human amniotic membrane product derived from placenta and umbilical cord
SalineOther
sterile, preservative free 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Micronized Amniotic Membrane | Experimental | Injection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl Receives: Other: Flo; Other: Saline |
| Preservative Free Normal Saline | Placebo comparator | 2.0 mL sterile, preservative free 0.9% NaCl Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Achilles pain
A score of 0 is considered no pain while a score of 10 is considered very severe pain
Measured: 30 days
Secondary outcomes (6)
Change from Baseline in NRS score
A score of 0 is considered no pain while a score of 10 is considered very severe pain
Measured: over 3 months
Change from Baseline in VISA-A score
Measured: over 3 months
Proportion of responders based on change in VISA-A score
20 points as a threshold for assignment of responder status
Measured: over 3 months
Proportion of complete pain relief
pain score of 0
Measured: over 3 months
Time to complete pain relief
pain score of 0
Measured: over 3 months
Proportion of subjects that respond feeling at least better and satisfied
patient satisfaction survey
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start22 Nov 2023
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Park Podiatry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trent Brookshier, North Park Podiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172218
- Sponsor's protocol ID
- 2023-001
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Pilot Study Assessing Micronized Amniotic Membrane and Umbilical Cord Particulate in Patients With Symptomatic and Refractory Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT06172218
- Acronym / sponsor ID
- 2023-001
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- North Park PodiatryUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronized Amniotic Membrane | Experimental | Other: Flo, Other: SalineInjection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl |
| Preservative Free Normal Saline | Placebo comparator | Other: Saline2.0 mL sterile, preservative free 0.9% NaCl |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flosterile, micronized human amniotic membrane product derived from placenta and umbilical cord | Other | Micronized Amniotic Membrane |
| Salinesterile, preservative free 0.9% NaCl | Other | Micronized Amniotic Membrane, Preservative Free Normal Saline |
Primary outcome
Change in Achilles pain
Time frame: 30 days
A score of 0 is considered no pain while a score of 10 is considered very severe pain
6 secondary outcomes
Change from Baseline in NRS score
Time frame: over 3 months
Change from Baseline in VISA-A score
Time frame: over 3 months
Proportion of responders based on change in VISA-A score
Time frame: over 3 months
Proportion of complete pain relief
Time frame: over 3 months
Time to complete pain relief
Time frame: over 3 months
Proportion of subjects that respond feeling at least better and satisfied
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flo and Saline in people with Achilles Tendinopathy, run by North Park Podiatry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Achilles pain (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.