Recent Updates
Recently added Catalysts

NorLeu3-A in a formulation

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00796744Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic UlcersPHASE2 COMPLETED 78 — — Oct 1, 2008May 1, 2011Sep 27, 201212 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria