FlatfootNCT02706327

Comparison of Two Different Insole Types in Painful Flexible Flatfoot

A study testing CAD/CAM Insole and Semi-custom Insole in people with Flatfoot, run by Eastern Mediterranean University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Flatfoot
What is being tested?: CAD/CAM Insole and Semi-custom Insole
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: No sites listed yet
Study dates: Jan 2014to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
minimum of + 6 points on the foot posture index,

Who cannot join

treatment of the foot for at least six months,
leg length discrepancy of more than 1 cm,
history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.

About this study

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

Conditions: Flatfoot
Being tested: CAD/CAM Insole, Semi-custom Insole, Control
Keywords: orthotic insoles, pain, quality of life, athletic performance
Medical subject headings: Flatfoot, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02706327
Study group	Role	What they receive
CAD/CAM	Experimental	8-week follow-up with CAD/CAM insole and home based exercise program Receives: Device: CAD/CAM Insole
Semi-custom	Experimental	8-week follow-up with semi-custom insole and home based exercise program Receives: Device: Semi-custom Insole
Control	Placebo comparator	8-week follow-up with placebo insole and home based exercise program Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Intensity Measured by 100 mm Visual Analog Scale
The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels.
Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week.
Changes were calculated as the difference between 8-week follow-up and baseline results.
Measured: Baseline and week 8

Secondary outcomes (1)

Change in Quality of Life Assessed With Short Form-36 Scale
The scale scores the health related quality of life with 0 and 100, minimum and maximum levels.
Each question is scored between 0-100 and the total score is found by dividing to number of question.
Higher score or positive change mean better quality of life in the scale. We used physical health part of it.
Changes were calculated as the difference between 8-week follow-up and baseline results.
Measured: Baseline and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Feb 2016

First posted11 Mar 2016 (estimated)
Study startJan 2014
Primary completionJan 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FlatfootStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02706327
Sponsor's protocol ID: GO 14/18-31
Status last verified: Oct 2017
First submitted: 3 Mar 2016
Last updated: 1 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
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Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
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The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
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All Flatfoot trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
ClinicalTrials.gov ID: NCT02706327
Acronym / sponsor ID: GO 14/18-31
Conditions: Flatfoot
Keywords: orthotic insoles, pain, quality of life, athletic performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Eastern Mediterranean UniversityUniversity, hospital or other
Collaborators: Hacettepe University
Study start: Jan 2014
Primary completion: Jan 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 11 Mar 2016 (estimated)
Results: Posted 14 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
CAD/CAM	Experimental	Device: CAD/CAM Insole8-week follow-up with CAD/CAM insole and home based exercise program
Semi-custom	Experimental	Device: Semi-custom Insole8-week follow-up with semi-custom insole and home based exercise program
Control	Placebo comparator	Other: Control8-week follow-up with placebo insole and home based exercise program

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
minimum of + 6 points on the foot posture index,

Key exclusion criteria (3 listed)

treatment of the foot for at least six months,
leg length discrepancy of more than 1 cm,
history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CAD/CAM InsoleA 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.	Device	CAD/CAM
Semi-custom InsolePlantar 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.	Device	Semi-custom
Control15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.	Other	Control

Primary outcome

Change in Pain Intensity Measured by 100 mm Visual Analog Scale
Time frame: Baseline and week 8
The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results.

1 secondary outcome

Change in Quality of Life Assessed With Short Form-36 Scale
Time frame: Baseline and week 8

Results and safety

Results posted to the registry on 14 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAD/CAM	22	21
Semi-custom	22	21
Control	23	21

Primary outcome: Change in Pain Intensity Measured by 100 mm Visual Analog Scale

Time frame: Baseline and week 8. Mean (Standard Deviation). Unit: milimiters

Measure	CAD/CAM n = 22	Semi-custom n = 22	Control n = 23
Value	-31.40 (18.50)	-34.54 (14.24)	-12.08 (11.82)

CAD/CAM vs Semi-custom vs Control: p <0.001, Kruskal-Wallis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through 8-week follow up period.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAD/CAM	0 of 22 (0%)	0 of 22 (0%)	Not reported
Semi-custom	0 of 22 (0%)	0 of 22 (0%)	Not reported
Control	0 of 23 (0%)	1 of 23 (4.3%)	Not reported

Limitations and caveats (from the sponsor): The young average age of our study population could limit the generalizability of our results and the two-month follow-up interval was sufficient to see the benefit of insoles but may not be long enough to determine whether the benefit will last.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Flatfoot

Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yasin Yurt, Dr. principal investigator

Eastern Mediterranean University

Questions about this trial

What is this clinical trial studying?

A study testing CAD/CAM Insole and Semi-custom Insole in people with Flatfoot, run by Eastern Mediterranean University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity Measured by 100 mm Visual Analog Scale (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.