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Detection of Diabetic Foot Skin Damage Using Plantar Mechanical Parameters

NCT07470255 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-03-13

No results posted yet for this study

Summary

Diabetes represents one of the major chronic diseases, with diabetic ulcers being a significant adverse prognosis. Approximately 80% of lower limb amputations are attributed to diabetic foot ulcers, which constitute a primary cause of patient disability and mortality, while also imposing a substantial burden on healthcare systems. Although standardized Western medical protocols for diabetic foot management exist, clinical outcomes remain suboptimal. The amputation rate due to diabetic foot ulcers continues to rise annually, underscoring the urgent need for novel and effective interventions to address this condition.

Quantitative assessment of cutaneous biomechanical parameters may indirectly reflect the cumulative damage inflicted by diabetes on foot tissues. Such evaluation provides critical guidance for predicting susceptibility to recurrent ulceration and determining the necessity of enhanced offloading strategies to prevent ulcer development. By applying specific mechanical loads to the skin and measuring deformation, rebound characteristics, and displacement dynamics under pressure, it becomes possible to quantitatively evaluate parameters such as elastic modulus and viscoelastic properties.

This case-control study aims to investigate the feasibility of utilizing plantar skin quantitative mechanical parameters as objective biomarkers for biomechanical impairment in diabetic foot. Furthermore, it seeks to establish a standardized operating procedure (SOP) for quantitative measurements tailored to diabetic foot scenarios. The study is designed to bridge critical evidence gaps between theoretical consensus and clinically applicable quantitative tools, demonstrating clear innovation and potential clinical value.

Conditions

  • Diabetic Foot Disease
  • Diabete Mellitus
  • Mechanical Factor

Interventions

DIAGNOSTIC_TEST

Detection of the elastic modulus of the plantar skin

This study utilizes a quantitative mechanical measurement apparatus, developed by Professor Cao's research team at Tsinghua University. The device employs the principles of straw mechanics and indentation mechanics to apply standardized mechanical loads-such as negative pressure and mechanical contact pressure-to the skin surface while quantitatively measuring its deformation. This enables the precise assessment of skin hardness and viscoelasticity, thereby facilitating the digitization and standardization of skin biomechanical property evaluations.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-04-01
Completion
2028-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470255 on ClinicalTrials.gov