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NCT Number: NCT07470255

Detection of Diabetic Foot Skin Damage Using Plantar Mechanical Parameters

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For healthy one: Fasting blood glucose < 6.1 mmol/L and glycated hemoglobin < 6.0%, with no history of diabetes; Foot condition: normal appearance of both feet, without wounds, deformities, trauma, infections, or dermatological disorders; voluntary participation in this study with signed informed consent.
  • For diabetic one: Confirmation of type 1 or type 2 diabetes mellitus as defined by the World Health Organization (WHO) diagnostic standards; Diagnosis of diabetic foot disease* consistent with the criteria established by the International Working Group on the Diabetic Foot (IWGDF); Voluntary participation in the present study with provision of signed informed consent.

Exclusion criteria

  • For healthy one: (1) History of foot surgery, trauma, or fractures resulting in skin scars or irreversible cutaneous damage; (2) Active chronic dermatological conditions affecting skin integrity, such as tinea pedis, eczema, or psoriasis; (3) Vascular diseases of the lower extremities (e.g., arteriosclerosis obliterans) causing muscular or cutaneous atrophy in the feet; (4) Systemic diseases impacting the skin or connective tissues, including systemic sclerosis, rheumatoid arthritis, or vasculitis; (5) Prolonged engagement in heavy physical labor or professional sports leading to abnormal thickening or hyperkeratosis of the plantar skin; (6) Presence of extensive, hyperkeratotic lesions (e.g., calluses, corns) or wounds at the measurement site impairing probe contact accuracy; (7) Inability to cooperate or diagnosed psychiatric disorders; (8) Investigator-determined unsuitability for the study or inability to comply with protocol requirements.
  • For diabetic one: (1) Uncontrolled severe acute foot infections; (2) Dermatological conditions that interfere with measurement procedures; (3) Irreversible foot skin damage due to non-diabetic etiologies such as trauma or surgical intervention; (4) Coexisting systemic disorders (excluding diabetes) that compromise skin elasticity, including systemic sclerosis, rheumatoid arthritis, or vasculitis; (5) History of above-knee amputation on the measured foot; (6) Inability to cooperate or presence of psychiatric disorders; (7) Investigator-determined ineligibility due to non-compliance concerns or unsuitability for study participation.

Treatment and study plan

Detection of the elastic modulus of the plantar skin

Diagnostic Test

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.

Primary outcomes

  1. Skin elastic modulus (kPa)

    Time frame: Baseline

Secondary outcomes

  1. Degree of skin creep

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Long Zhang Executive Deputy Director, Medical Doctor

CONTACT

[email protected]

+86 010-82266699

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

An Exploratory Study on the Detection of Diabetic Foot Skin Damage Using Quantitative Mechanical Parameters of Plantar Skin

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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