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Dermagraft, Comparator

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment595

FDA Designations

No designations recorded

Clinical trial landscape

Dermagraft, Comparator · 2 trials · 1 indication

Phase 3 2
NCT01181453Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot UlcersDiabetic Foot Ulcer
COMPLETED314 Analytics
NCT01181440Dermagraft(R) for the Treatment of Patients With Diabetic Foot UlcersDiabetic Foot Ulcer
COMPLETED281 Analytics
PHASE3COMPLETED
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
Diabetic Foot UlcerUnlock trial analytics
PHASE3COMPLETED
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
Diabetic Foot UlcerUnlock trial analytics

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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Frequently asked questions about Dermagraft, Comparator

What is Dermagraft used for?

Dermagraft is an investigational product being studied for the treatment of diabetic foot ulcers and venous leg ulcers. It is developed by Organogenesis Holdings Inc. (ORGO) and is currently in Phase 3 clinical development. Two Phase 3 trials have been completed, one for each indication.

Who makes Dermagraft?

Dermagraft is developed by Organogenesis Holdings Inc., a company traded on the stock exchange under the ticker ORGO. The company is conducting clinical trials to evaluate the product for diabetic foot ulcers and venous leg ulcers.

What phase is Dermagraft in?

Dermagraft is in Phase 3 clinical development. It is not FDA approved and remains investigational. Two Phase 3 trials have been completed, one for venous leg ulcers and two for diabetic foot ulcers, with a total enrollment of 595 patients across all trials.

What clinical trials is Dermagraft in?

Dermagraft has completed three Phase 3 trials. NCT00909870 studied Dermagraft for venous leg ulcers with 537 participants. NCT01181440 and NCT01181453 studied Dermagraft for diabetic foot ulcers, enrolling 281 and 314 participants respectively. All trials are completed.

Is Dermagraft the same as Comparator?

No, Dermagraft and Comparator are not the same. Dermagraft is the investigational product being studied, while Comparator refers to the control group in the clinical trials. The trials are uncontrolled, meaning they do not use a comparator arm.