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

NCT07164495 | Recruiting

• 1 other identifier: CMUH113-REC1-169
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Type 2

Keywords

Diabetes; Gait; Plantar Pressure

Outcome Measures

Primary Outcomes (1)

• plantar pressure

  Pressure insole will be inserted into the standard shoes to record plantar pressure values during level walking

  Day 1: a single time point

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

those diagnosed with type 2 diabetes

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead
• China Medical University, Taiwan: collaborator

Study Sites (1)

China Medical University, Department of Physical Therapy

Taichung, Taiwan, 406040, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Hsiu-Chen Lin, PhD

CONTACT

+886422053366; hclin@mail.cmu.edu.tw

Ming-Chen Hsieh, MD, PhD

CONTACT

+886-3-5580-558

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)