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NorLeu3-A in a formulation

Phase 2

Foot Ulcer, Diabetic | Small molecule | Metabolic |Integra LifeSciences Holdings Corporation|Last Updated: Sep 27, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

NorLeu3-A in a formulation · 1 trial · 2 indications

Phase 2 1
NCT00796744Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic UlcersFoot Ulcer, Diabetic
COMPLETED78 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
Foot Ulcer, DiabeticUnlock trial analytics

Study Endpoints

Primary Endpoints

The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.
Healing to occur within 12 weeks of first treatment

Secondary Endpoints

The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
Duration of subject's participation (24 weeks)
The Rate of Re-epithelialization of the Ulcer Site.
12 weeks
The Time to Re-epithelialization of the Ulcer Site.
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo Vehicle ControlPLACEBO_COMPARATORcontrol placebo vehicle gel
0.03% DSC127ACTIVE_COMPARATOR0.03 % DSC127 in Vehicle Control
0.01% DSC127ACTIVE_COMPARATOR0.01% DSC127 in Vehicle Control

Interventions

NameTypeDescription
NorLeu3-A(1-7) in a gel formulationDRUGGel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.0-6.0 cm2 on the midfoot or forefoot, including the toes but excluding the heel. * ABI greater than 0.7 for neuroischemic or greater than 0.8 for neuropathic DU * TcPO2...

Countries:United States
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Frequently asked questions about NorLeu3-A in a formulation

What is NorLeu3-A in a formulation used for?

NorLeu3-A in a formulation is being studied for the treatment of diabetic foot ulcers, a type of foot ulcer that occurs in people with diabetes. It is an investigational small molecule therapy currently in clinical development for this condition.

What does NorLeu3-A in a formulation target?

The specific molecular target of NorLeu3-A in a formulation has not been disclosed. It is a small molecule being investigated for its potential to treat diabetic foot ulcers, but its mechanism of action is not publicly detailed.

Who makes NorLeu3-A in a formulation?

NorLeu3-A in a formulation is being developed by Integra LifeSciences Holdings Corporation, a company traded on the NASDAQ under the ticker symbol IART.

What phase is NorLeu3-A in a formulation in?

NorLeu3-A in a formulation is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of diabetic foot ulcers.

What clinical trials is NorLeu3-A in a formulation in?

NorLeu3-A in a formulation has been studied in one completed Phase 2 clinical trial, identified as NCT00796744. This trial, titled 'Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers,' enrolled 78 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is NorLeu3-A in a formulation the same as DSC127?

Yes, NorLeu3-A in a formulation is also known as DSC127. The clinical trial NCT00796744, which studied this drug for diabetic foot ulcers, refers to it as DSC127.