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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, Diabetic
NCT0079674478
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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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