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CompletedNCT02810002Updated Jun 22, 2016

Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

A Phase 1/2 interventional study of Experimental infantry boot - DEFINITE-REGULATOR and Control infantry boot in Blister, Abrasion and Stress Fracture, sponsored by Medical Corps, Israel Defense Force. Completed. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-22.

Sponsored by Medical Corps, Israel Defense Force · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Blister
  • Abrasion
  • Stress Fracture
  • Ankle Sprain
  • Patellofemoral Pain Syndrome
  • Back Pain
03

In context

Blister

36 studies on the registry are indexed under Blister; 3 are open to participants now.

This study's enrollment of 98 is above the median of 65 across 24 interventional studies indexed under Blister.

Browse Blister studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infantry recruits on selected base

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    DEFINITE-REGULATOR

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

    Device: Experimental infantry boot - DEFINITE-REGULATOR

  • Active comparator
    modified Belleville 390 TROP

    Standard issue infantry boot

    Device: Control infantry boot

Interventions

  • DeviceExperimental infantry boot - DEFINITE-REGULATOR

    Training: infantry basic training in the experimental boots

  • DeviceControl infantry boot

    Training: infantry basic training in the control boots

06

What researchers measure

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

    Time frame: 14 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 28265448 ↗

Individual participant data

Plan to share: Yes — Raw unidentified data available by contacting the PI

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02810002
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
Sponsor
First posted
Jun 22, 2016
Start date
Aug 2014
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Jun 22, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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