search
Back to results

Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

Primary Purpose

Blister, Abrasion, Stress Fracture

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Experimental infantry boot - DEFINITE-REGULATOR
Control infantry boot
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blister

Eligibility Criteria

18 Years - 25 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Infantry recruits on selected base

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DEFINITE-REGULATOR

    modified Belleville 390 TROP

    Arm Description

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

    Standard issue infantry boot

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 16, 2016
    Last Updated
    June 19, 2016
    Sponsor
    Medical Corps, Israel Defense Force
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02810002
    Brief Title
    Assessing Foot Injuries in Infantry Recruits Wearing Different Boots
    Official Title
    Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical Corps, Israel Defense Force

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    One hundred infantry recruits will be randomly assigned to two groups. Injuries will be monitored.
    Detailed Description
    One hundred infantry recruits will be randomly assigned to receive experimental infantry boots (DEFINITE-REGULATOR) or standard issued boots (modified Belleville 390 TROP). Overuse injuries and foot injuries will be monitored over a period of 14 weeks. The intervention group will wear experimental infantry boots and the controls will wear standard issue boots.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DEFINITE-REGULATOR
    Arm Type
    Experimental
    Arm Description
    Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
    Arm Title
    modified Belleville 390 TROP
    Arm Type
    Active Comparator
    Arm Description
    Standard issue infantry boot
    Intervention Type
    Device
    Intervention Name(s)
    Experimental infantry boot - DEFINITE-REGULATOR
    Intervention Description
    Training: infantry basic training in the experimental boots
    Intervention Type
    Device
    Intervention Name(s)
    Control infantry boot
    Intervention Description
    Training: infantry basic training in the control boots
    Primary Outcome Measure Information:
    Title
    Number of recruits with at least one injury related to the boots
    Description
    Injuries assessed: Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Infantry recruits on selected base Exclusion Criteria: None

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Raw unidentified data available by contacting the PI
    Citations:
    PubMed Identifier
    28265448
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

    We'll reach out to this number within 24 hrs