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Micronized Amniotic Membrane for Achilles Tendinopathy

N/A

Recruiting

Research Sponsored by North Park Podiatry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 18 to 64 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is studying the effects of membrane tissue replacement to treat Achilles tendon injuries that don't respond to conventional care.

Who is the study for?

This trial is for people with chronic Achilles tendinopathy that hasn't improved with standard treatments. Specific details about who can join or reasons why someone might not be able to participate are not provided.Check my eligibility

What is being tested?

The study is testing the effectiveness of micronized amniotic membrane (Flo) compared to a saline solution in treating Achilles tendinopathy. It's a pilot study, meaning it's preliminary research before a larger-scale trial.See study design

What are the potential side effects?

Potential side effects are not detailed in the information provided, but could include typical reactions to implant materials or injections such as pain, swelling, and infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have tried physical therapy for Achilles tendinopathy, including 6 weeks of specific exercises.

Select...

I am between 18 and 64 years old.

Select...

I have had Achilles tendon pain for at least 3 months, confirmed by an ultrasound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Achilles pain

Secondary outcome measures

Change from Baseline in NRS score

Change from Baseline in VISA-A score

Proportion of complete pain relief

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Micronized Amniotic MembraneExperimental Treatment2 Interventions

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

Group II: Preservative Free Normal SalinePlacebo Group1 Intervention

2.0 mL sterile, preservative free 0.9% NaCl

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

North Park PodiatryLead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you have any age restrictions for participation in this experimental protocol?

"To be considered eligible for this trial, participants must fall between the ages of 18 and 64. Additionally, there are 3 studies specifically designed to accommodate minors as well as 60 trials that cater towards patients above 65 years old."

Answered by AI

Do I qualify to enlist in this research venture?

"Participants between 18 and 64 years old with achilles tendinopathy are invited to apply for this trial, which seeks 20 total participants."

Answered by AI

How many individuals have volunteered to participate in this research initiative?

"Affirmative. The information available on clinicaltrials.gov reveals that this research is presently recruiting participants, with the trial having been first posted on November 22nd 2023 and recently updated on December 7th 2023. The team requires 20 individuals to be recruited from a single medical facility for participation in the study."

Answered by AI

Is there still availability for people to participate in this trial?

"Evidently, this clinical trial is actively recruiting patients as per the information on clinicaltrials.gov. This investigation was first listed in November of 2023 and most recently amended a few weeks later in December."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AM for Refractory Achilles Tendinopathy

Trent Brookshier 2023. "AM for Refractory Achilles Tendinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06172218.