Risk Factors for Developing Peak Plantar Pressure During Walking in the Diabetic Patients

NCT ID: NCT07164495

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-03-31

Brief 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 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.

Conditions

Diabete Type 2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• severe deformity in the foot or lower extremity
• significant neuropathic or surgical diseases that affect normal walking function
• cognitive dysfunction
• active foot ulcer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University, Taiwan

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsiu-Chen Lin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China Medical University, Department of Physical Therapy

Taichung, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsiu-Chen Lin, PhD

Role: CONTACT

hclin@mail.cmu.edu.tw

+886422053366 ext. 7303

Ming-Chen Hsieh, MD, PhD

Role: CONTACT

+886-3-5580-558

Facility Contacts

Hsiu-Chen Lin

Role: primary

hclin@mail.cmu.edu.tw

0422053366

Other Identifiers

CMUH113-REC1-169

Identifier Type: -

Identifier Source: org_study_id