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Feet First

Phase 1

Diabetes Mellitus | Unknown | Neurology |Johnson & Johnson|Last Updated: Oct 5, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00286598Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate FeetPHASE1 COMPLETED 79Jan 1, 2005Jun 1, 2008Oct 5, 20161 United States
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Study Endpoints
Primary Endpoints
Change in weight-bearing physical activity (steps/day)
Baseline, 3, 6 and 12 months post-enrollment
Secondary Endpoints
Partial or greater depth foot ulcer (Wagner Gr. 1 or deeper)
continuously post-enrollment for 12 months
Falls
continuously post-enrollment for 12 months
Self-reported foot disability
baseline, 6 and 12 months post enrollment
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Feet FirstEXPERIMENTALPhase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.
ControlNO_INTERVENTIONUsual care
Interventions
NameTypeDescription
Feet FirstBEHAVIORALPhase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed type 1 or 2 diabetes mellitus * Age 50 years or older * Absent 5.07 Semmes Weinstein monofilament sensation to \> 1 point on both feet * Residence within 50 miles of Columbia, MO * Functioning telephone service * Not currently participating in 20 or more minutes of m...

Countries:United States
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