Diabetic Foot3DP-DPNNCT07641764
3D Printed vs Ready-to-Wear Insoles for Diabetic Neuropathy
A study testing 3D Printed Customized Insole and Ready-to-Wear Insole in people with Diabetic Foot and Diabetic Neuropathies, run by University of Faisalabad at 1 site in Pakistan.
Trial summary
Diabetic neuropathy is a condition caused by chronic high blood glucose levels that damage nerves over time, frequently causing abnormal plantar pressure and increasing the risk of foot ulcers and impaired mobility. Insoles are widely used to redistribute pressure and improve comfort. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetic Foot, Diabetic Neuropathies
- What is being tested?
- 3D Printed Customized Insole and Ready-to-Wear Insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35 to 65 years
- Diagnosed with diabetes mellitus
- Clinical diagnosis of diabetic peripheral neuropathy
- Ability to walk independently without walking aids
- Normal cognitive function
- Corrected or uncorrected vision sufficient for safe ambulation
- Willingness to provide written informed consent
Who cannot join
- Presence of active foot ulcer
- External wound on lower extremity
- History of lower limb surgery within past 6 months
- Major lower limb amputation
- Foot drop
- Peripheral vascular disease
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- Neuromuscular diseases (e.g., stroke, Parkinson's disease, multiple sclerosis)
- Charcot arthropathy
- Inability to comply with study protocol
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Faisalabad
Faisalābad, Punjab Province, 3800
About this study
Official title: Comparative Effect of 3D Printed Customized Insoles and Ready to Wear Insoles on Plantar Pressure Changes in Patients With Diabetic Neuropathy
Diabetic neuropathy is a condition caused by chronic high blood glucose levels that damage nerves over time, frequently causing abnormal plantar pressure and increasing the risk of foot ulcers and impaired mobility. Insoles are widely used to redistribute pressure and improve comfort. This study compares the effect of 3D printed customized insoles versus ready-to-wear insoles on plantar pressure changes in patients with diabetic neuropathy. The study is a randomized controlled trial with 22 participants randomly allocated to two groups: one receiving 3D printed customized insoles and the other receiving ready-to-wear insoles. Plantar pressure is measured using piezoresistive sensors and an Arduino Nano Unit. Secondary outcomes include foot health status (FSHQ questionnaire), satisfaction with assistive technology (QUEST 2.0), and neuropathy severity (NSS and NDS questionnaires). Assessments occur at baseline, 4 weeks, and 8 weeks.
Read the detailed description
This is a single-blind, parallel-group randomized controlled trial conducted at DHQ-1 and DHQ-2 hospitals in Okara, Pakistan. Participants are adults aged 35-65 years with diagnosed diabetic neuropathy who can walk independently without aids. Exclusion criteria include foot ulcers, external wounds, recent surgery, major limb amputation, foot drop, peripheral vascular disease, neuromuscular diseases, and Charcot arthropathy. A consecutive sampling technique is used to recruit 22 participants. Randomization is performed using a computer-generated sequence. Participants are blinded to their group allocation. Group A receives 3D printed customized insoles tailored to individual foot morphology using 3D scanning and printing technology. These insoles provide arch support and gait alignment. Group B receives ready-to-wear insoles providing general cushioning and basic support. Both groups follow an 8-week intervention protocol: participants wear insoles for a minimum of 6 hours per day, 5 days per week, and perform level walking on a 28-meter pathway at self-selected speed. The protocol is divided into phases: weeks 1-2 for acclimatization and footwear assessment using Semmes-Weinstein 10g monofilament; weeks 3-4 for pressure adaptation and skin monitoring; weeks 5-6 for enhanced foot function and balance improvement; weeks 7-8 for final assessment. Primary outcome: plantar pressure measured via piezoresistive sensors and Arduino Nano Unit. Secondary outcomes: Foot Health Status Questionnaire (FSHQ), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), Neuropathy Symptom Score (NSS), and Neuropathy Deficit Score (NDS). Data are collected at baseline, week 4, and week 8. Statistical analysis uses SPSS version 22.
- Conditions
- Diabetic Foot, Diabetic Neuropathies
- Being tested
- 3D Printed Customized Insole, Ready-to-Wear Insole
- Keywords
- 3D printing, customized insoles, plantar pressure, diabetic neuropathy, Pakistan
- Medical subject headings
- Diabetic Foot, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Customized InsoleDevice
3D printed customized insoles are fabricated using 3D scanning of the participant's foot to capture individual morphology. The insoles are printed using thermoplastic polyurethane (TPU) or similar 3D printing filament. The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks. Participants perform level walking on a 28-meter pathway at self-selected speed. Weekly assessments monitor adherence, skin condition, and comfort. Patient education on foot care and insole use is provided.
Ready-to-Wear InsoleDevice
Ready-to-wear insoles are prefabricated insoles providing general cushioning and shock absorption. These insoles are not customized to individual foot morphology. The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks. Participants perform level walking on a 28-meter pathway at self-selected speed. Weekly assessments monitor adherence, skin condition, and comfort. Patient education on foot care and insole use is provided.
| Study group | Role | What they receive |
|---|---|---|
| Group A: 3D Printed Customized Insoles | Experimental | Participants in this group receive 3D printed customized insoles tailored to individual foot morphology. Insoles are designed to provide arch support and gait alignment. Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following a phased protocol of acclimatization, pressure adaptation, and function improvement. Receives: Device: 3D Printed Customized Insole; Device: Ready-to-Wear Insole |
| Group B: Ready-to-Wear Insoles | Active comparator | Participants in this group receive prefabricated ready-to-wear insoles providing general cushioning and basic support. Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following the same phased protocol as the experimental group. Receives: Device: Ready-to-Wear Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plantar Pressure Distribution
Plantar pressure is measured using piezoresistive sensors connected to an Arduino Nano Unit. Participants walk barefoot across the sensor platform. The sensor records pressure distribution across the plantar surface in kilopascals (kPa). Higher pressure values indicate greater plantar load, which is associated with increased risk of foot ulceration. Lower pressure values indicate better offloading.
Measured: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Secondary outcomes (1)
Foot Health Status Questionnaire (FSHQ) Score
The Foot Health Status Questionnaire (FSHQ) is a validated instrument assessing foot-related quality of life. It includes domains of foot pain, foot function, footwear, and general foot health. Each item is scored on a Likert scale. Minimum score is zero and maximum score is 100. scores are generally classified into ranges such as Very Low: 0-24.9 Low:25-49.9 Medium: 50-74.9 High: 75-100 HIgher score indicates better foot health and lower score indicates worst foot health.
Measured: Baseline (Week 0), Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anbreena Rasool, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641764
- Sponsor's protocol ID
- TUF/EIRB/ 195 /26
- Acronym
- 3DP-DPN
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of 3D Printed Customized Insoles and Ready to Wear Insoles on Plantar Pressure Changes in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT07641764
- Acronym / sponsor ID
- 3DP-DPN / TUF/EIRB/ 195 /26
- Conditions
- Diabetic Foot, Diabetic Neuropathies
- Keywords
- 3D printing, customized insoles, plantar pressure, diabetic neuropathy, Pakistan
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Jun 2026 (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.
Diabetic neuropathy is a condition caused by chronic high blood glucose levels that damage nerves over time, frequently causing abnormal plantar pressure and increasing the risk of foot ulcers and impaired mobility. Insoles are widely used to redistribute pressure and improve comfort. This study compares the effect of 3D printed customized insoles versus ready-to-wear insoles on plantar pressure changes in patients with diabetic neuropathy. The study is a randomized controlled trial with 22 participants randomly allocated to two groups: one receiving 3D printed customized insoles and the other receiving ready-to-wear insoles. Plantar pressure is measured using piezoresistive sensors and an Arduino Nano Unit. Secondary outcomes include foot health status (FSHQ questionnaire), satisfaction with assistive technology (QUEST 2.0), and neuropathy severity (NSS and NDS questionnaires). Assessments occur at baseline, 4 weeks, and 8 weeks.
Detailed description
This is a single-blind, parallel-group randomized controlled trial conducted at DHQ-1 and DHQ-2 hospitals in Okara, Pakistan. Participants are adults aged 35-65 years with diagnosed diabetic neuropathy who can walk independently without aids. Exclusion criteria include foot ulcers, external wounds, recent surgery, major limb amputation, foot drop, peripheral vascular disease, neuromuscular diseases, and Charcot arthropathy. A consecutive sampling technique is used to recruit 22 participants. Randomization is performed using a computer-generated sequence. Participants are blinded to their group allocation. Group A receives 3D printed customized insoles tailored to individual foot morphology using 3D scanning and printing technology. These insoles provide arch support and gait alignment. Group B receives ready-to-wear insoles providing general cushioning and basic support. Both groups follow an 8-week intervention protocol: participants wear insoles for a minimum of 6 hours per day, 5 days per week, and perform level walking on a 28-meter pathway at self-selected speed. The protocol is divided into phases: weeks 1-2 for acclimatization and footwear assessment using Semmes-Weinstein 10g monofilament; weeks 3-4 for pressure adaptation and skin monitoring; weeks 5-6 for enhanced foot function and balance improvement; weeks 7-8 for final assessment. Primary outcome: plantar pressure measured via piezoresistive sensors and Arduino Nano Unit. Secondary outcomes: Foot Health Status Questionnaire (FSHQ), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), Neuropathy Symptom Score (NSS), and Neuropathy Deficit Score (NDS). Data are collected at baseline, week 4, and week 8. Statistical analysis uses SPSS version 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 3D Printed Customized Insoles | Experimental | Device: 3D Printed Customized Insole, Device: Ready-to-Wear InsoleParticipants in this group receive 3D printed customized insoles tailored to individual foot morphology. Insoles are designed to provide arch support and gait alignment. Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following a phased protocol of acclimatization, pressure adaptation, and function improvement. |
| Group B: Ready-to-Wear Insoles | Active comparator | Device: Ready-to-Wear InsoleParticipants in this group receive prefabricated ready-to-wear insoles providing general cushioning and basic support. Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following the same phased protocol as the experimental group. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 35 to 65 years
- Diagnosed with diabetes mellitus
- Clinical diagnosis of diabetic peripheral neuropathy
- Ability to walk independently without walking aids
- Normal cognitive function
Key exclusion criteria (9 listed)
- Presence of active foot ulcer
- External wound on lower extremity
- History of lower limb surgery within past 6 months
- Major lower limb amputation
- Foot drop
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 |
|---|---|---|
| 3D Printed Customized Insole3D printed customized insoles are fabricated using 3D scanning of the participant's foot to capture individual morphology. The insoles are printed using thermoplastic polyurethane (TPU) or similar 3D printing filament. The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks. Participants perform level walking on a 28-meter pathway at self-selected speed. Weekly assessments monitor adherence, skin condition, and comfort. Patient education on foot care and insole use is provided. | Device | Group A: 3D Printed Customized Insoles |
| Ready-to-Wear InsoleReady-to-wear insoles are prefabricated insoles providing general cushioning and shock absorption. These insoles are not customized to individual foot morphology. The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks. Participants perform level walking on a 28-meter pathway at self-selected speed. Weekly assessments monitor adherence, skin condition, and comfort. Patient education on foot care and insole use is provided. | Device | Group A: 3D Printed Customized Insoles, Group B: Ready-to-Wear Insoles |
Primary outcome
Change in Plantar Pressure Distribution
Time frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Plantar pressure is measured using piezoresistive sensors connected to an Arduino Nano Unit. Participants walk barefoot across the sensor platform. The sensor records pressure distribution across the plantar surface in kilopascals (kPa). Higher pressure values indicate greater plantar load, which is associated with increased risk of foot ulceration. Lower pressure values indicate better offloading.
1 secondary outcome
Foot Health Status Questionnaire (FSHQ) Score
Time frame: Baseline (Week 0), Week 4, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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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 3D Printed Customized Insole and Ready-to-Wear Insole in people with Diabetic Foot and Diabetic Neuropathies, run by University of Faisalabad at 1 site in Pakistan.
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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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 Plantar Pressure Distribution (time frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)). 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 17 Jun 2026.