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Dermagraft,Comparator

Phase 3

Diabetic Foot Ulcer | Unknown | Other |Organogenesis Holdings Inc.|Last Updated: May 20, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials2
Total Enrollment595
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01181453Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot UlcersPHASE3 COMPLETED 314Dec 1, 1998Mar 1, 2000May 20, 2018 -
NCT01181440Dermagraft(R) for the Treatment of Patients With Diabetic Foot UlcersPHASE3 COMPLETED 281Sep 1, 1994Jan 1, 1997May 20, 2018 -
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Study Design & Arms
Interventions
NameTypeDescription
DermagraftDEVICEWeekly application of Dermagraft(R) with standard care
ComparatorOTHERWeekly application of standard care
Dermagraft(R)DEVICEWeekly application of Dermagraft(R) with conventional care
Conventional careOTHERWeekly application of conventional care
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