CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
CAD/CAM Insole +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02706327
NCT02706327N/ACompleted

Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot

Eastern Mediterranean University·interventional·Posted Mar 11, 2016·Updated Nov 1, 2017

In Brief

A clinical study evaluating CAD/CAM Insole, Semi-custom Insole, and 1 other intervention for Flatfoot. Completed, enrolled 67 participants.

Detailed Summary

The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFlatfoot
Countries--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 11, 2016
Enrollment StartJan 1, 2014
Primary CompletionJan 1, 2016
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.3 years ago

Interventions

CAD/CAM Insoledevice

A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Semi-custom Insoledevice

Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Controlother

15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.