Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

June 19, 2016 updated by: Medical Corps, Israel Defense Force

Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Infantry recruits on selected base

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEFINITE-REGULATOR
Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
Device: Experimental infantry boot - DEFINITE-REGULATOR
Training: infantry basic training in the experimental boots
Active Comparator: modified Belleville 390 TROP
Standard issue infantry boot
Device: Control infantry boot
Training: infantry basic training in the control boots

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of recruits with at least one injury related to the boots
Time Frame: 14 weeks
Injuries assessed: Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Corps, Israel Defense Force

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 19, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDF-1346-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw unidentified data available by contacting the PI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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