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Dermagraft, Profore

Phase 3

Venous Leg Ulcer | Unknown | Other |Takeda Pharmaceutical Company Limited|Last Updated: Aug 21, 2013

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment225

FDA Designations

No designations recorded

Clinical trial landscape

Dermagraft, Profore · 1 trial · 1 indication

Phase 3 1
NCT01891760Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg UlcersVenous Leg Ulcer
COMPLETED225 Analytics
PHASE3COMPLETED
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Venous Leg UlcerUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence of study ulcer recurrence
1 year

Secondary Endpoints

Incidence of complete study ulcer healing
1 year
Incidence of study ulcer infection-related events
1 year
Time to study ulcer recurrence
1 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTALDermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold
Reference TherapyACTIVE_COMPARATORProfore - Four-layer compression bandaging therapy

Interventions

NameTypeDescription
DermagraftDEVICEDermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
ProforeDEVICEFour-layer compression bandaging therapy.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: 1. Subject has completed study ABH-Dermagraft-001-08 2. Subject understands study requirements 3. Subject is available to participate in the 1 year-long observational follow-up. Exclusion Criteria: 1. Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before com...

Countries:United StatesEstoniaGermanyPolandSouth AfricaUnited Kingdom
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Frequently asked questions about Dermagraft, Profore

What is Dermagraft used for?

Dermagraft is used for the treatment of venous leg ulcers. It is an investigational product that has been studied in a Phase 3 clinical trial. The trial was a long-term follow-up to the DEVO pivotal trial, which evaluated Dermagraft in patients with venous leg ulcers.

Who makes Dermagraft?

Dermagraft is being developed by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker TAK. The company conducted a Phase 3 clinical trial to evaluate the product for the treatment of venous leg ulcers.

What phase is Dermagraft in?

Dermagraft is in Phase 3 clinical development. It has been studied in a Phase 3 trial that has been completed. The trial was a long-term follow-up to the DEVO pivotal trial, which evaluated Dermagraft for the treatment of venous leg ulcers.

What clinical trials is Dermagraft in?

Dermagraft has been studied in one clinical trial with the identifier NCT01891760. This Phase 3 trial was a long-term follow-up to the DEVO pivotal trial of Dermagraft for treating venous leg ulcers. The trial enrolled 225 participants and has been completed.

Is Dermagraft the same as Profore?

Dermagraft is also known as Profore. Both names refer to the same product, which is being developed by Takeda Pharmaceutical Company Limited for the treatment of venous leg ulcers. The product has been evaluated in a Phase 3 clinical trial.