NCT02667990

Brief Summary

22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer. Testing involves pedobar pressures and a validated comfort questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

August 28, 2015

Last Update Submit

January 28, 2016

Conditions

Metatarsalgia

Keywords

metatarsalgiapedobarfootstilettoinsoles

Outcome Measures

Primary Outcomes (1)

  • plantar foot pressure

    Mean and peak pressure and pressure/time in the heel, arch and fore foot ( fore foot subdivided into 1. metatarsal head, 2+3 rd head, 4+5th head and the big toe). Pressure measured as Newton/sq. cm.

    1 hrs

Secondary Outcomes (1)

  • comfort rating footwear

    1 month

Other Outcomes (1)

  • X ray angles of the foot

    1 hrs

Study Arms (1)

orthopaedic stilettoe

EXPERIMENTAL

orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer

Other: orthopaedic stilettoeOther: standard stilettoOther: comfy trainer

Interventions

orthopaedic stilettoeOTHER

stilettos with orthopaedic in-sole buildt into the shoe

orthopaedic stilettoe
standard stilettoOTHER

standard stiletto without insole

orthopaedic stilettoe
comfy trainerOTHER

comfy trainer

orthopaedic stilettoe

Eligibility Criteria

Age18 Years - 67 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Foot healthy females used to wearing stilettos.

You may not qualify if:

  • Shoe sized outside European 37-42.
  • Sought doctor for foot or balance related issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

Foot DiseasesMusculoskeletal DiseasesJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • jeannette penny, PhD

    Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
orthopedic surgeon, PhD.

Study Record Dates

First Submitted

August 28, 2015

First Posted

January 29, 2016

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

DK(1)