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An Exploratory Study on the Detection of Diabetic Foot Skin Damage Using Quantitative Mechanical Parameters of Plantar Skin
Sponsor study identifier
observational
200
0 countries
N/A
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 7, 2026
Actual (reported)March 13, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Skin elastic modulus (kPa)
Baseline
Degree of skin creep
Baseline
patient with diabetic foot， with or without ulcer，ulcer has been healing or not
people not with diabetic foot
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.
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both healthy people and diabetic foot patient.
[1] Li Y, Teng D, Shi X, et al. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross-sectional study. BMJ. 2020 Apr 28;369:m997. [2] Edmonds M. A renaissance in diabetic foot care: new evidence-based treatments. Lancet Diabetes Endocrinol. 2018;6(11):837-838. [3] Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: a clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016;63(2)(suppl):3S-21S. [4] McDermott K, Fang M, Boulton AJM, et al. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care. 2023 Jan 1;46(1):209-221. [5] Argyropoulos AJ, Robichaud P, Balimunkwe RM, Fisher GJ, Hammerberg C, Yan Y, Quan T. Alterations of Dermal Connective Tissue Collagen in Diabetes: Molecular Basis of Aged-Appearing Skin. PLoS One. 2016 Apr 22;11(4):e0153806. [6] Boulton AJ, Hardisty CA, Betts RP, Franks CI, Worth RC, Ward JD, Duckworth T. Dynamic foot pressure and other studies as diagnostic and management aids in diabetic neuropathy. Diabetes Care. 1983 Jan-Feb;6(1):26-33. [7] Cavanagh PR, Bus SA. Off-loading the diabetic foot for ulcer prevention and healing. J Vasc Surg. 2010 Sep;52(3 Suppl):37S-43S. [8] Bus SA, de Lange A. A comparison of the 1-step, 2-step, and 3-step protocols for obtaining barefoot plantar pressure data in the diabetic neuropathic foot. Clin Biomech (Bristol). 2005 Nov;20(9):892-9. [9] van Netten JJ, Price PE, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Bus SA; International Working Group on the Diabetic Foot. Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:84-98. [10] Abbott CA, Chatwin KE, Foden P, Hasan AN, Sange C, Rajbhandari SM, Reddy PN, Vileikyte L, Bowling FL, Boulton AJM, Reeves ND. Innovat
First Submitted
March 7, 2026
First Posted
March 13, 2026
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2027
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 13, 2026
Record last verified: 2026-03
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