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Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02810002
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force

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

Condition or disease Intervention/treatment Phase
Blister Abrasion Stress Fracture Ankle Sprain Patellofemoral Pain Syndrome Back Pain Device: Experimental infantry boot - DEFINITE-REGULATOR Device: Control infantry boot Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Infantry recruits on selected base

Exclusion Criteria:

  • None
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medical Corps, Israel Defense Force Identifier: NCT02810002    
Other Study ID Numbers: IDF-1346-2014
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw unidentified data available by contacting the PI
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Ankle Injuries
Fractures, Stress
Foot Injuries
Leg Injuries
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Fractures, Bone