Diabete Type 2NCT07164495
Risk Factors for Developing Peak Plantar Pressure During Walking in the Diabetic Patients
An observational study of Diabete Type 2, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to investigate the clinically convenient dynamic and static measurement parameters to identify related risk factors of developing high peak plantar pressure during walking in the type-2 diabetic patients, and then establish a predictive model to estimate the likelihood of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 31 Mar 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: those diagnosed with type 2 diabetes
Who may be able to join
- diagnosed with type 2 diabetes, at least for five years
- aged older than 18 years
- walk independently for at least 10 meter without any assistive device
Who cannot join
- severe deformity in the foot or lower extremity
- significant neuropathic or surgical diseases that affect normal walking function
- cognitive dysfunction
- active foot ulcer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ming-Chen Hsieh, MD, PhD contact
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University, Department of Physical Therapy
Taichung, Taiwan, 406040
Hsiu-Chen Lin, 0422053366, hclin@mail.cmu.edu.tw
About this study
Official title: Investigation of the Risk Factors and Establishing a Prediction Model for Developing Peak Foot Pressure During Walking in the Diabetic Patients
The goal of this observational study is to investigate the clinically convenient dynamic and static measurement parameters to identify related risk factors of developing high peak plantar pressure during walking in the type-2 diabetic patients, and then establish a predictive model to estimate the likelihood of excessive plantar pressure.
The main question it aims to answer is:
Which clinical measurements may be used as the predictors that increased peak plantar pressure in the type-2 diabetic patients? Participants taking the examinations will understand their own clinally meaningful measurements related to their plantar pressure during walking. Further thorough analysis will be employed to develop a predictive model, aiming to provide potential improvement strategies for preventing diabetic foot ulcers in the future.
Read the detailed description
Diabetes is one of the top three chronic diseases among the population, with type 2 diabetes accounting for 90% of all cases. Due to decreased insulin sensitivity, the body cannot effectively store glucose in muscle, fat, and liver cells, leading to elevated blood sugar levels. This condition often results in various comorbidities and complications, with diabetic peripheral neuropathy (DPN) being the most prominent. DPN symptoms include loss of sensation to pain, pressure, vibration, proprioception, and temperature changes, which can lead to foot ulcers and altered gait in patients. The primary risk factor for diabetic foot ulcers is excessive or concentrated plantar pressure. Currently, the main preventive measure for diabetic foot ulcers is the use of insoles or footwear to reduce foot pressure. However, the difficulty in obtaining plantar pressure monitoring equipment limits its widespread clinical use. In contrast, assessments of foot morphology and range of motion (ROM), as well as the application of new sensors for gait kinematic measurement, are relatively convenient for clinical use. Therefore, this study aims to establish the relationship between peak plantar pressure during walking in diabetic patients and clinically convenient dynamic and static measurement parameters, identify related risk factors, and develop a predictive model to estimate the likelihood of excessive plantar pressure.
The study plans to recruit 120 diabetic patients, using the NDS scale to measure participants' neuropathy disability levels, Von Frey monofilaments to assess plantar sensation, goniometers to record joint angles of the first metatarsophalangeal joint, ankle, and knee, graph paper to record foot shape, RehaGait(R) gait analysis system to record walking kinematics, and Noraxon(R) Ultium Insole to record plantar pressure values. Subsequently, correlation analysis will be used to identify the relationship between joint angles, foot shape, walking kinematics, and peak plantar pressure values, while chi-square tests will identify significant risk factors. Finally, multiple regression analysis will be employed to develop a predictive model, aiming to provide potential improvement strategies for preventing diabetic foot ulcers in the future.
- Conditions
- Diabete Type 2
- Keywords
- Diabetes, Gait, Plantar Pressure
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes | 1. Diagnosed with type 2 diabetes; 2. Able to walk at least 10 meters independently without any assistive device; 3. Age > 18 years. 4. No acute foot ulcers, any lower limb deformity or surgery, neurological disease that may affect walking function. 5. No Cognitive impairment and inability to follow instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
plantar pressure
Pressure insole will be inserted into the standard shoes to record plantar pressure values during level walking
Measured: Day 1: a single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2024
- Primary completion31 Dec 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, Taiwan
- Responsible party
- Principal investigator, Hsiu-Chen Lin, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164495
- Sponsor's protocol ID
- CMUH113-REC1-169
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2025
- Last updated
- 28 Jan 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Risk Factors and Establishing a Prediction Model for Developing Peak Foot Pressure During Walking in the Diabetic Patients
- ClinicalTrials.gov ID
- NCT07164495
- Acronym / sponsor ID
- CMUH113-REC1-169
- Conditions
- Diabete Type 2
- Keywords
- Diabetes, Gait, Plantar Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, Taiwan
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 10 Sep 2025 (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.
The goal of this observational study is to investigate the clinically convenient dynamic and static measurement parameters to identify related risk factors of developing high peak plantar pressure during walking in the type-2 diabetic patients, and then establish a predictive model to estimate the likelihood of excessive plantar pressure.
The main question it aims to answer is:
Which clinical measurements may be used as the predictors that increased peak plantar pressure in the type-2 diabetic patients? Participants taking the examinations will understand their own clinally meaningful measurements related to their plantar pressure during walking. Further thorough analysis will be employed to develop a predictive model, aiming to provide potential improvement strategies for preventing diabetic foot ulcers in the future.
Detailed description
Diabetes is one of the top three chronic diseases among the population, with type 2 diabetes accounting for 90% of all cases. Due to decreased insulin sensitivity, the body cannot effectively store glucose in muscle, fat, and liver cells, leading to elevated blood sugar levels. This condition often results in various comorbidities and complications, with diabetic peripheral neuropathy (DPN) being the most prominent. DPN symptoms include loss of sensation to pain, pressure, vibration, proprioception, and temperature changes, which can lead to foot ulcers and altered gait in patients. The primary risk factor for diabetic foot ulcers is excessive or concentrated plantar pressure. Currently, the main preventive measure for diabetic foot ulcers is the use of insoles or footwear to reduce foot pressure. However, the difficulty in obtaining plantar pressure monitoring equipment limits its widespread clinical use. In contrast, assessments of foot morphology and range of motion (ROM), as well as the application of new sensors for gait kinematic measurement, are relatively convenient for clinical use. Therefore, this study aims to establish the relationship between peak plantar pressure during walking in diabetic patients and clinically convenient dynamic and static measurement parameters, identify related risk factors, and develop a predictive model to estimate the likelihood of excessive plantar pressure.
The study plans to recruit 120 diabetic patients, using the NDS scale to measure participants' neuropathy disability levels, Von Frey monofilaments to assess plantar sensation, goniometers to record joint angles of the first metatarsophalangeal joint, ankle, and knee, graph paper to record foot shape, RehaGait(R) gait analysis system to record walking kinematics, and Noraxon(R) Ultium Insole to record plantar pressure values. Subsequently, correlation analysis will be used to identify the relationship between joint angles, foot shape, walking kinematics, and peak plantar pressure values, while chi-square tests will identify significant risk factors. Finally, multiple regression analysis will be employed to develop a predictive model, aiming to provide potential improvement strategies for preventing diabetic foot ulcers in the future.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes | – | –1. Diagnosed with type 2 diabetes; 2. Able to walk at least 10 meters independently without any assistive device; 3. Age > 18 years. 4. No acute foot ulcers, any lower limb deformity or surgery, neurological disease that may affect walking function. 5. No Cognitive impairment and inability to follow instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- those diagnosed with type 2 diabetes
Key inclusion criteria (3 listed)
- diagnosed with type 2 diabetes, at least for five years
- aged older than 18 years
- walk independently for at least 10 meter without any assistive device
Key exclusion criteria (4 listed)
- severe deformity in the foot or lower extremity
- significant neuropathic or surgical diseases that affect normal walking function
- cognitive dysfunction
- active foot ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
plantar pressure
Time frame: Day 1: a single time point
Pressure insole will be inserted into the standard shoes to record plantar pressure values during level walking
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 28 Jan 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.
Ming-Chen Hsieh, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 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 Taiwan. 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?
Contact Hsiu-Chen Lin, PhD (+886422053366 ext. 7303, hclin@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plantar pressure (time frame: Day 1: a single time point). 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 28 Jan 2026.