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NCT Number: NCT07164495

Risk Factors for Developing Peak Plantar 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University, Department of Physical Therapy

Taichung, Taiwan, 406040

Location status: Recruiting

Location contact

Hsiu-Chen Lin

CONTACT

[email protected]

0422053366

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hsiu-Chen Lin, PhD

CONTACT

[email protected]

+886422053366 ext. 7303

Ming-Chen Hsieh, MD, PhD

CONTACT

+886-3-5580-558

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • China Medical University, Taiwan

Registry information

Official study title

Investigation of the Risk Factors and Establishing a Prediction Model for Developing Peak Foot Pressure During Walking in the Diabetic Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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