Plantar FasciitisInsolesNCT06563492
The Effect of Insoles in Plantar Fasciitis
A study testing Custom-Made CNC-Milled EVA Insole and Custom-Made FDM 3D-Printed TPU Insole in people with Plantar Fasciitis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized active-comparator clinical trial compared changes over 12 weeks between customized computer numerical control (CNC)-milled ethylene-vinyl acetate (EVA) and fused deposition modelling (FDM) 3D-printed thermoplastic polyurethane (TPU) insoles with plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Custom-Made CNC-Milled EVA Insole and Custom-Made FDM 3D-Printed TPU Insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2024to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Clinical diagnosis of plantar fasciitis by a specialist physician
- Clinical indication or prescription for custom-made foot orthoses
- Plantar fasciitis symptoms lasting for at least 3 months
- Heel pain localized to the plantar-medial calcaneal tubercle
- First-step pain in the morning or pain during the first steps after a period of rest
- Roles and Maudsley score of 3 or 4 at the baseline assessment
- Ability and willingness to provide written informed consent and comply with the study procedures
Who cannot join
- Body mass index greater than 30 kg/m²
- Presence of a clinically relevant cardiopulmonary, dermatological, neurological or musculoskeletal condition other than plantar fasciitis that could affect walking, plantar loading, pain assessment or participation in the study
- History of foot or ankle surgery
- Requirement for a walking assistive device during the study assessments
- Inability or unwillingness to wear footwear compatible with the assigned foot orthoses
- Cognitive or psychiatric condition that could prevent understanding of the study instructions, provision of informed consent or completion of the assessments
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Prosthetics and Orthotics Center (POMER)
Beykoz, Istanbul, 34815
About this study
Official title: Effects of Custom Made EVA and 3D-Printed TPU Insoles on Gastrocnemius Muscle Activation and Static Pedobarographic Parameters in Plantar Fasciitis
This randomized active-comparator clinical trial compared changes over 12 weeks between customized computer numerical control (CNC)-milled ethylene-vinyl acetate (EVA) and fused deposition modelling (FDM) 3D-printed thermoplastic polyurethane (TPU) insoles with plantar fasciitis. The primary outcome was bilateral gastrocnemius medialis and lateralis muscle activation recorded using surface electromyography during a standardized 10-meter walking task. Secondary outcomes included static plantar loading, pain, foot-related function, and user satisfaction. Because both groups received custom-made insoles as active interventions, the trial was designed to compare the two orthosis types rather than to determine the absolute efficacy of insoles.
Read the detailed description
Plantar fasciitis is a common cause of plantar heel pain that may limit weight-bearing activities and reduce foot-related function. Custom-made insoles are frequently used in conservative management; however, direct evidence comparing orthoses produced using different materials and manufacturing methods remains limited.
This study was designed as an exploratory, parallel-group, randomized active-comparator trial. Forty-one participants with plantar fasciitis were randomly allocated to receive either a custom-made ethylene-vinyl acetate (EVA) insole manufactured using computer numerical control (CNC) milling or a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing. Participants were assessed at baseline and after 12 weeks of orthosis use.
The primary objective was to compare the effects of the two orthosis types on static plantar loading characteristics and gastrocnemius muscle activation. Static plantar loading was evaluated using pedobarography. Surface electromyography was used to record the activity of the bilateral gastrocnemius medialis and lateralis muscles during a standardized 10-metre walking task. Electromyographic measurements were normalized to maximum voluntary contraction recordings obtained during standardized plantar-flexion and dorsiflexion tasks. The 10-metre walk was used as the standardized task during which electromyographic data were collected and was not evaluated as a walking-performance outcome.
Secondary assessments included pain intensity, pressure pain threshold, foot-related function and participant satisfaction with the assigned orthosis. Pain intensity was evaluated under different symptom-provoking conditions, including first-step morning pain, pain during palpation and pain associated with prolonged standing.
Because both groups received custom-made insole as active interventions and the study did not include a sham, usual-care or untreated control group, the trial was designed to compare the two orthosis types rather than to determine the absolute efficacy of insoles. Accordingly, the findings were intended to describe between-group differences between CNC-milled EVA and FDM 3D-printed TPU insoles over the 12-week follow-up period.
- Conditions
- Plantar Fasciitis
- Being tested
- Custom-Made CNC-Milled EVA Insole, Custom-Made FDM 3D-Printed TPU Insole
- Keywords
- plantar fasciitis, Plantar heel pain, Custom-made insole, Ethylene-vinyl acetate, Thermoplastic polyurethane, Three-dimensional printing, Pedobarography, Surface electromyography, Gastrocnemius muscle activation
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-Made CNC-Milled EVA InsoleDevice
A custom-made insole was individually manufactured from ethylene-vinyl acetate (EVA) using computer numerical control (CNC) milling. Participants used the assigned insole for 12 weeks.
Custom-Made FDM 3D-Printed TPU InsoleDevice
A custom-made insole was individually manufactured from thermoplastic polyurethane (TPU) using fused deposition modelling (FDM) three-dimensional printing. Participants used the assigned insole for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CNC-Milled EVA Insole | Active comparator | Participants assigned to this active-comparator arm received a custom-made ethylene-vinyl acetate (EVA) insole manufactured using computer numerical control (CNC) milling and were instructed to use the assigned orthosis for 12 weeks. Receives: Device: Custom-Made CNC-Milled EVA Insole |
| FDM 3D-Printed TPU Insole | Experimental | Participants assigned to this experimental arm received a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing and were instructed to use the assigned orthosis for 12 weeks. Receives: Device: Custom-Made FDM 3D-Printed TPU Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Gastrocnemius Muscle Activation During a Standardized 10-Metre Walking Task
Surface electromyography was recorded bilaterally from the gastrocnemius medialis and gastrocnemius lateralis muscles during a standardized 10-metre walking task. The processed parameters included maximum EMG envelope amplitude and mean-maximum, minimum-peak and maximum-peak activation values normalized to maximum voluntary contraction (%MVC). MVC recordings were obtained during standardized plantar-flexion and dorsiflexion tasks. Higher %MVC values indicate greater muscle activation relative to MVC. The 10-metre walk was used solely as the standardized task for EMG recording and was not evaluated as a walking-performance outcome.
Measured: Baseline and Week 12
Secondary outcomes (5)
Change From Baseline in Affected Foot Loading Assessed by Static Pedobarography
Static pedobarography was performed during quiet standing to quantify plantar load distribution. Rearfoot loading of the affected foot was expressed as a percentage of the total plantar load for that foot, ranging from 0% to 100%, with higher values indicating greater relative rearfoot loading. Affected and unaffected feet were coded before analysis. Because forefoot and rearfoot loading percentages are mathematically complementary, forefoot loading was not treated as a separate independent endpoint.
Measured: Baseline and Week 12
Change From Baseline in Foot-Related Function Assessed by the Foot Function Index
Foot-related function was evaluated using the 23-item Foot Function Index, comprising pain, disability and activity-limitation subscales. Subscale and total scores are expressed on a scale from 0 to 100, with higher scores indicating greater pain, disability or activity limitation.
Measured: Baseline and Week 12
Change From Baseline in Pain Intensity Assessed by the Visual Analogue Scale
Pain intensity was assessed using a 10-cm Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. First-step morning pain, pain during palpation of the plantar heel and pain associated with prolonged standing were recorded and analyzed as separate pain scores.
Measured: Baseline and Week 12
Change From Baseline in Plantar Heel Pressure Pain Threshold
Pressure pain threshold at the plantar heel was measured using a pressure algometer and expressed in kg/cm². Higher values indicate a greater pressure pain threshold and lower pressure sensitivity.
Measured: Baseline and Week 12
Participant Satisfaction With the Assigned Insoles Assessed by Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-2.0).
Participant satisfaction was assessed at Week 12 using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). The 12-item instrument comprises eight items evaluating satisfaction with the assistive device and four items evaluating satisfaction with related services. Each item is scored from 1 (not satisfied at all) to 5 (very satisfied). Device, service and total QUEST scores are calculated by averaging the applicable item scores, with higher scores indicating greater satisfaction. Participants also identify the three satisfaction items they consider most important; these responses were summarized descriptively.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start16 Dec 2024
- Primary completion6 Jan 2025
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants were randomly assigned in parallel to one of two active intervention groups: a custom-made ethylene-vinyl acetate (EVA) foot orthosis manufactured using computer numerical control (CNC) milling or a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing. Outcome assessments were scheduled at baseline and at week 12.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande YAZICI, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563492
- Sponsor's protocol ID
- HYAZICI
- Acronym
- Insoles
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No formal plan was established to share de-identified individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Custom Made EVA and 3D-Printed TPU Insoles on Gastrocnemius Muscle Activation and Static Pedobarographic Parameters in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06563492
- Acronym / sponsor ID
- Insoles / HYAZICI
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fasciitis, Plantar heel pain, Custom-made insole, Ethylene-vinyl acetate, Thermoplastic polyurethane, Three-dimensional printing, Pedobarography, Surface electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized active-comparator clinical trial compared changes over 12 weeks between customized computer numerical control (CNC)-milled ethylene-vinyl acetate (EVA) and fused deposition modelling (FDM) 3D-printed thermoplastic polyurethane (TPU) insoles with plantar fasciitis. The primary outcome was bilateral gastrocnemius medialis and lateralis muscle activation recorded using surface electromyography during a standardized 10-meter walking task. Secondary outcomes included static plantar loading, pain, foot-related function, and user satisfaction. Because both groups received custom-made insoles as active interventions, the trial was designed to compare the two orthosis types rather than to determine the absolute efficacy of insoles.
Detailed description
Plantar fasciitis is a common cause of plantar heel pain that may limit weight-bearing activities and reduce foot-related function. Custom-made insoles are frequently used in conservative management; however, direct evidence comparing orthoses produced using different materials and manufacturing methods remains limited.
This study was designed as an exploratory, parallel-group, randomized active-comparator trial. Forty-one participants with plantar fasciitis were randomly allocated to receive either a custom-made ethylene-vinyl acetate (EVA) insole manufactured using computer numerical control (CNC) milling or a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing. Participants were assessed at baseline and after 12 weeks of orthosis use.
The primary objective was to compare the effects of the two orthosis types on static plantar loading characteristics and gastrocnemius muscle activation. Static plantar loading was evaluated using pedobarography. Surface electromyography was used to record the activity of the bilateral gastrocnemius medialis and lateralis muscles during a standardized 10-metre walking task. Electromyographic measurements were normalized to maximum voluntary contraction recordings obtained during standardized plantar-flexion and dorsiflexion tasks. The 10-metre walk was used as the standardized task during which electromyographic data were collected and was not evaluated as a walking-performance outcome.
Secondary assessments included pain intensity, pressure pain threshold, foot-related function and participant satisfaction with the assigned orthosis. Pain intensity was evaluated under different symptom-provoking conditions, including first-step morning pain, pain during palpation and pain associated with prolonged standing.
Because both groups received custom-made insole as active interventions and the study did not include a sham, usual-care or untreated control group, the trial was designed to compare the two orthosis types rather than to determine the absolute efficacy of insoles. Accordingly, the findings were intended to describe between-group differences between CNC-milled EVA and FDM 3D-printed TPU insoles over the 12-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in parallel to one of two active intervention groups: a custom-made ethylene-vinyl acetate (EVA) foot orthosis manufactured using computer numerical control (CNC) milling or a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing. Outcome assessments were scheduled at baseline and at week 12.
| Arm | Type | Receives |
|---|---|---|
| CNC-Milled EVA Insole | Active comparator | Device: Custom-Made CNC-Milled EVA InsoleParticipants assigned to this active-comparator arm received a custom-made ethylene-vinyl acetate (EVA) insole manufactured using computer numerical control (CNC) milling and were instructed to use the assigned orthosis for 12 weeks. |
| FDM 3D-Printed TPU Insole | Experimental | Device: Custom-Made FDM 3D-Printed TPU InsoleParticipants assigned to this experimental arm received a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing and were instructed to use the assigned orthosis for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18 and 65 years
- Clinical diagnosis of plantar fasciitis by a specialist physician
- Clinical indication or prescription for custom-made foot orthoses
- Plantar fasciitis symptoms lasting for at least 3 months
- Heel pain localized to the plantar-medial calcaneal tubercle
Key exclusion criteria (7 listed)
- Body mass index greater than 30 kg/m²
- Presence of a clinically relevant cardiopulmonary, dermatological, neurological or musculoskeletal condition other than plantar fasciitis that could affect walking, plantar loading, pain assessment or participation in the study
- History of foot or ankle surgery
- Requirement for a walking assistive device during the study assessments
- Inability or unwillingness to wear footwear compatible with the assigned foot orthoses
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 |
|---|---|---|
| Custom-Made CNC-Milled EVA InsoleA custom-made insole was individually manufactured from ethylene-vinyl acetate (EVA) using computer numerical control (CNC) milling. Participants used the assigned insole for 12 weeks. | Device | CNC-Milled EVA Insole |
| Custom-Made FDM 3D-Printed TPU InsoleA custom-made insole was individually manufactured from thermoplastic polyurethane (TPU) using fused deposition modelling (FDM) three-dimensional printing. Participants used the assigned insole for 12 weeks. | Device | FDM 3D-Printed TPU Insole |
Primary outcome
Change From Baseline in Gastrocnemius Muscle Activation During a Standardized 10-Metre Walking Task
Time frame: Baseline and Week 12
Surface electromyography was recorded bilaterally from the gastrocnemius medialis and gastrocnemius lateralis muscles during a standardized 10-metre walking task. The processed parameters included maximum EMG envelope amplitude and mean-maximum, minimum-peak and maximum-peak activation values normalized to maximum voluntary contraction (%MVC). MVC recordings were obtained during standardized plantar-flexion and dorsiflexion tasks. Higher %MVC values indicate greater muscle activation relative to MVC. The 10-metre walk was used solely as the standardized task for EMG recording and was not evaluated as a walking-performance outcome.
5 secondary outcomes
Change From Baseline in Affected Foot Loading Assessed by Static Pedobarography
Time frame: Baseline and Week 12
Change From Baseline in Foot-Related Function Assessed by the Foot Function Index
Time frame: Baseline and Week 12
Change From Baseline in Pain Intensity Assessed by the Visual Analogue Scale
Time frame: Baseline and Week 12
Change From Baseline in Plantar Heel Pressure Pain Threshold
Time frame: Baseline and Week 12
Participant Satisfaction With the Assigned Insoles Assessed by Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-2.0).
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. No formal plan was established to share de-identified individual participant data with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-Made CNC-Milled EVA Insole and Custom-Made FDM 3D-Printed TPU Insole in people with Plantar Fasciitis, run by Medipol University at 1 site in Turkey (Türkiye).
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 8 inclusion and 7 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 From Baseline in Gastrocnemius Muscle Activation During a Standardized 10-Metre Walking Task (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.