Factors that cause high pressure under the feet during walking in people with type 2 diabetes
Official title: Investigation of the Risk Factors and Establishing a Prediction Model for Developing Peak Foot Pressure During Walking in the Diabetic Patients
Run by China Medical University Hospital · NCT07164495 · Data updated 2026-11-12
This study will see if easy clinic measurements like foot shape, joint motion, neuropathy score, and simple gait sensors can predict who with type 2 diabetes will have high peak pressure under their feet when walking.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung, Taiwan) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | March 31, 2026 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07164495 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with type 2 diabetes for at least five years who can walk 10 meters without assistive devices and who do not have active foot ulcers, severe foot deformity, major gait‑affecting surgical conditions, or cognitive impairment.
✕Probably not a fit
Patients with active foot ulcers, severe deformity of the foot or lower limb, significant neuropathic or surgical conditions that impair normal walking, or those unable to walk independently are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will recruit about 120 adults with type 2 diabetes (diagnosed for at least five years) who can walk 10 meters unaided. Investigators will record static foot morphology, joint range of motion, neuropathy disability scores (NDS), and gait kinematics with wearable sensors, alongside direct plantar pressure measurements during walking. Statistical analysis will identify which routine clinical and gait measures are linked to high peak plantar pressure and will be used to build a predictive model. The model aims to point to practical, clinic-friendly markers that could guide prevention strategies such as footwear, insoles, or gait therapy.
Why it matters
Potential benefit: If successful, this work could help clinicians identify patients at risk for excessive plantar pressure so they can offer targeted footwear, insoles, or gait interventions to lower the chance of diabetic foot ulcers.
How similar studies have gone: Prior research has established a link between high plantar pressure and diabetic foot ulcer risk and there are some predictive tools, but using routine clinical foot and gait measures to predict peak plantar pressure is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
China Medical University, Department of Physical Therapy
Taichung, Taiwan, Taiwan Recruiting
Study contacts
- Study coordinator: Hsiu-Chen Lin, PhD
- Email: hclin@mail.cmu.edu.tw
- Phone: +886422053366
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.