Factors that cause high pressure under the feet during walking in people with type 2 diabetes

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

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
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China Medical University Hospital (other)
• Locations: 1 site (Taichung, Taiwan)
• Trial ID: NCT07164495 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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

Where this trial is running

Taichung, Taiwan

• China Medical University, Department of Physical Therapy — Taichung, Taiwan, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Hsiu-Chen Lin, PhD

Conditions: Diabete Type 2, Diabetes, Gait, Plantar Pressure