NCT02810002

Brief Summary

One hundred infantry recruits will be randomly assigned to two groups. Injuries will be monitored.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
Last Updated

June 22, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

June 16, 2016

Last Update Submit

June 19, 2016

Conditions

BlisterAbrasionStress FractureAnkle SprainPatellofemoral Pain SyndromeBack Pain

Outcome Measures

Primary Outcomes (1)

  • Number of recruits with at least one injury related to the boots

    Injuries assessed: Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain

    14 weeks

Study Arms (2)

DEFINITE-REGULATOR

EXPERIMENTAL

Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel

Device: Experimental infantry boot - DEFINITE-REGULATOR

modified Belleville 390 TROP

ACTIVE COMPARATOR

Standard issue infantry boot

Device: Control infantry boot

Interventions

Experimental infantry boot - DEFINITE-REGULATORDEVICE

Training: infantry basic training in the experimental boots

DEFINITE-REGULATOR
Control infantry bootDEVICE

Training: infantry basic training in the control boots

modified Belleville 390 TROP

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infantry recruits on selected base

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Milgrom C, Sorkin A, Gam A, Singer J, Nir I, Kogan B, Finestone AS. The search for the best infantry boot. Disaster Mil Med. 2016 Oct 10;2:14. doi: 10.1186/s40696-016-0024-5. eCollection 2016.

    PMID: 28265448DERIVED

MeSH Terms

Conditions

BlisterFractures, StressAnkle InjuriesPatellofemoral Pain SyndromeBack Pain

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsFractures, BoneWounds and InjuriesLeg InjuriesJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 22, 2016

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 22, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Raw unidentified data available by contacting the PI