Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT06172218
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AM for Refractory Achilles Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Achilles pain', 'timeFrame': '30 days', 'description': 'A score of 0 is considered no pain while a score of 10 is considered very severe pain'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in NRS score', 'timeFrame': 'over 3 months', 'description': 'A score of 0 is considered no pain while a score of 10 is considered very severe pain'}, {'measure': 'Change from Baseline in VISA-A score', 'timeFrame': 'over 3 months'}, {'measure': 'Proportion of responders based on change in VISA-A score', 'timeFrame': 'over 3 months', 'description': '20 points as a threshold for assignment of responder status'}, {'measure': 'Proportion of complete pain relief', 'timeFrame': 'over 3 months', 'description': 'pain score of 0'}, {'measure': 'Time to complete pain relief', 'timeFrame': 'over 3 months', 'description': 'pain score of 0'}, {'measure': 'Proportion of subjects that respond feeling at least better and satisfied', 'timeFrame': '3 months', 'description': 'patient satisfaction survey'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achilles Tendinopathy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 64 years old\n2. BMI ≤ 40 kg/m2\n3. Subject has been diagnosed with unilateral Achilles tendinopathy (based on investigator assessment using ultrasound) of at least 3 months duration\n4. 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\n5. VISA-A score for the target tendon ≥40 and ≤60 at screening\n6. Subject is willing to comply with all study procedures\n7. Willing to sign a written informed consent to participate\n8. Able to follow study instructions, with the intention of completing all required visits\n\nExclusion Criteria:\n\n1. Planned surgical procedure below knee of the targeted extremity during study period\n2. Patient has previously received an injection for this injury within the past 2 months\n3. Major lower limb amputation of the contralateral leg\n4. A medical condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial\n5. Osteoarthritis, chronic low back pain, fibromyalgia or any other condition that may affect the responses on the VISA-A\n6. HIV infection, Hepatitis B or C infection, tuberculosis, COVID-19, cellulitis or any other active infection\n7. Cognitive impairment, mental illness, neuroses, or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures\n8. Peritendinopathy, paratenonitis, partial tear or tendon rupture of the affected tendon\n9. Subject has hindfoot deformities on the targeted extremity\n10. 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\n11. Leg length discrepancy, hyperpronation, varus deformity of the forefoot, pes cavus or limited mobility of the subtalar joint\n12. Prior surgical intervention to the affected tendon\n13. Current use of vitamins or herbal supplements\n14. Current use of opioids, midazolam, gabapentin, pregabalin or ketamine\n15. Compensable disability or work injury, ongoing litigation, or ongoing chiropractic care\n16. Current use of systemic immunosuppressive medications, chemotherapy, or history of organ transplant (kidney, heart, lung)\n17. Pregnancy and women who are expecting to be pregnant\n18. Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study"}, 'identificationModule': {'nctId': 'NCT06172218', 'briefTitle': 'AM for Refractory Achilles Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'North Park Podiatry'}, 'officialTitle': 'Prospective, Randomized Controlled Pilot Study Assessing Micronized Amniotic Membrane and Umbilical Cord Particulate in Patients With Symptomatic and Refractory Achilles Tendinopathy', 'orgStudyIdInfo': {'id': '2023-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Micronized Amniotic Membrane', 'description': 'Injection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl', 'interventionNames': ['Other: Flo', 'Other: Saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Preservative Free Normal Saline', 'description': '2.0 mL sterile, preservative free 0.9% NaCl', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Flo', 'type': 'OTHER', 'description': 'sterile, micronized human amniotic membrane product derived from placenta and umbilical cord', 'armGroupLabels': ['Micronized Amniotic Membrane']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'sterile, preservative free 0.9% NaCl', 'armGroupLabels': ['Micronized Amniotic Membrane', 'Preservative Free Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92104', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'T Brookshier, DPM', 'role': 'CONTACT'}, {'role': 'CONTACT', 'phone': '(619) 283-2097'}], 'facility': 'North Park Podiatry', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'T Brookshier, DPM', 'role': 'CONTACT', 'email': 'trentbrookshier@gmail.com', 'phone': '(619) 283-2097'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Park Podiatry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Podiatrist/ Founder', 'investigatorFullName': 'Trent Brookshier', 'investigatorAffiliation': 'North Park Podiatry'}}}}