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Feet First

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

Feet First · 1 trial · 2 indications

Phase 1 1
NCT00286598Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate FeetDiabetes Mellitus
COMPLETED79 Analytics
PHASE1COMPLETED
Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet
Diabetes MellitusUnlock trial analytics

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 to 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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Frequently asked questions about Feet First

What is Feet First used for?

Feet First is an investigational intervention being studied for use in diabetes mellitus, specifically in people with diabetes mellitus and insensate feet. It is being evaluated as a way to promote physical activity in this patient population. The drug is currently in Phase 1 clinical development.

Who makes Feet First?

Feet First is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research on this investigational intervention for patients with diabetes mellitus and peripheral neuropathies.

What phase is Feet First in?

Feet First is in Phase 1 clinical development. It is an investigational intervention and has not been approved by regulatory authorities. One clinical trial for Feet First has been completed, and the intervention remains under study for its potential use in diabetes mellitus.

What clinical trials is Feet First in?

Feet First has one completed clinical trial registered under NCT00286598, titled "Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet." This Phase 1 study enrolled 79 participants in the United States, with a minimum age of 50 years, and included both sexes.

Is Feet First the same as any other drug?

No alternative names for Feet First have been identified. The intervention is known by the name Feet First in clinical research, and no other drug names have been associated with it in the available information.