Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03414255 | Micronized dHACM Injectable for the Treatment of Achille Tendonitis | PHASE3 | COMPLETED | 146 | — | — | Jan 9, 2018 | Mar 30, 2021 | May 19, 2022 | 14 | United States |
Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
| Arm | Type | Description |
|---|---|---|
| Micronized DHACM | EXPERIMENTAL | 1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM) |
| Saline Injection | PLACEBO_COMPARATOR | Injection of 1mL 0.9% Sodium Chloride Injection, USP |
| Name | Type | Description |
|---|---|---|
| Micronized DHACM | BIOLOGICAL | 1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM). |
| Saline Injection | DRUG | Injection of 1mL 0.9% Sodium Chloride Injection, USP |
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...