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

Recruiting

• Conditions: Diabete Type 2

• Registration Number: NCT07164495
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plantar pressure	Day 1: a single time point	Pressure insole will be inserted into the standard shoes to record plantar pressure values during level walking

Trial Locations

Locations (1)

China Medical University, Department of Physical Therapy; 🇨🇳 Taichung, Taiwan, Taiwan