RECRUITING

AM for Refractory Achilles Tendinopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-22

Study Completion:2024-06-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06172218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

T Brookshier, DPM

CONTACT

(619) 283-2097

trentbrookshier@gmail.com

Study Locations (Sites)

North Park Podiatry

San Diego, California, 92104

United States

Collaborators and Investigators

Sponsor: North Park Podiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-22

Study Completion Date2024-06-28

Study Record Updates

Study Start Date2023-11-22

Study Completion Date2024-06-28

Terms related to this study

Additional Relevant MeSH Terms

Achilles Tendinopathy