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Micronized DHACM

Phase 3

Tendonitis;Achilles | Monoclonal antibody | Musculoskeletal |MiMedx Group, Inc|Last Updated: Dec 11, 2023

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical trial landscape

Micronized DHACM · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT03414255Micronized dHACM Injectable for the Treatment of Achille TendonitisTendonitis;Achilles
COMPLETED146 Analytics
PHASE3COMPLETED
Micronized dHACM Injectable for the Treatment of Achille Tendonitis
Tendonitis;AchillesUnlock trial analytics
Study Endpoints
Primary Endpoints
Change in VAS score
90 days

Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"

Incidence of adverse events
365 days

The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection

Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days
90 days

Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain

Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days
90 days

Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales: * Pain (5 questions) * Stiffness (2 questions) * Physical Function (17 questions) The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)
365 days

Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported

Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)
365 days

Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported

Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events
365 days

Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported

Secondary Endpoints
Foot Function Index Revised (FFI-R) (Short Form)
90 days
Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days
180 days
Secondary Endpoint:Change From Baseline in WOMAC at 180 Days
180 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Micronized DHACMEXPERIMENTAL1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM)
Saline InjectionPLACEBO_COMPARATORInjection of 1mL 0.9% Sodium Chloride Injection, USP
SalinePLACEBO_COMPARATORInjection of 0.9% Sodium Chloride Injection, USP
Interventions
NameTypeDescription
Micronized DHACMBIOLOGICAL1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).
Saline InjectionDRUGInjection of 1mL 0.9% Sodium Chloride Injection, USP
SalineDRUGInjection of 1 mL 0.9% Sodium Chloride, USP
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Eligibility Criteria
Age Range21 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria All subjects enrolled must meet all the following criteria: 1. Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator 2. VAS Pain scale of ≥ 45 at randomization 3. Achilles Tendonitis with conservative treatment for ≥1 month (30 da...

Countries:United States
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