Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT02810002
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE June 22, 2016
Last Update Posted Date June 22, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing Foot Injuries in Infantry Recruits Wearing Different Boots
Official Title  ICMJE Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Blister
  • Abrasion
  • Stress Fracture
  • Ankle Sprain
  • Patellofemoral Pain Syndrome
  • Back Pain
Intervention  ICMJE
  • Device: Experimental infantry boot - DEFINITE-REGULATOR
    Training: infantry basic training in the experimental boots
  • Device: Control infantry boot
    Training: infantry basic training in the control boots
Study Arms  ICMJE
  • Experimental: DEFINITE-REGULATOR
    Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
    Intervention: Device: Experimental infantry boot - DEFINITE-REGULATOR
  • Active Comparator: modified Belleville 390 TROP
    Standard issue infantry boot
    Intervention: Device: Control infantry boot
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2016)
98
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infantry recruits on selected base

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02810002
Other Study ID Numbers  ICMJE IDF-1346-2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Raw unidentified data available by contacting the PI
Responsible Party Medical Corps, Israel Defense Force
Study Sponsor  ICMJE Medical Corps, Israel Defense Force
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical Corps, Israel Defense Force
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP