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Radiation-Free Rapid Foot Bone Assessment Based on External Shape

Development and Validation of a Radiation-Free, Rapid, Precision Foot Screening System for Large Populations via Bone-Surface Morphology Correlation

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129487
Enrollment
Unknown
Registered
2026-08-05
Start date
2026-05-19
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flatfoot (pes planus / flexible flatfoot)

Interventions

Gold Standard:Weight-Bearing Computed Tomography (WBCT) using Siemens cone-beam/weight-bearing CT system to acquire 3D bony structure under weight-bearing condition, measuring Meary's angle, calcaneal
Index test:3D laser foot scanner (XPOD SS2V5.5.5, Wuhan Weima Technology) acquired foot surface morphology data, and the deep-learning prediction model (GCN/Point Transformer) built upon it to derive

Sponsors

Shanghai Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 80 Years

Inclusion criteria

Inclusion criteria: Prospective criteria: 1. Aged 8–80 years, any gender; 2. Body Mass Index (BMI) < 30 kg/m^2; 3. Able to stand independently and complete weight-bearing scanning; 4. Understand the study content and sign written informed consent (for minor subjects, the legal guardian shall understand the study content and sign written informed consent; the subject themselves shall provide written or oral assent according to their cognitive ability). Retrospective criteria: 1. Underwent foot and ankle WBCT examination at Shanghai Sixth People's Hospital from January 2023 to December 2025 (no age restriction for the retrospective part); 3D laser scanning was not performed on these patients; 2. Complete clinical data available.

Exclusion criteria

Exclusion criteria: 1. (Prospective) Previous ankle/foot fracture, surgery, or severe trauma; 2. (Prospective) Pregnant or planning pregnancy; 3. (Prospective) Unable to tolerate standing scan; 4. (Prospective) Foot skin damage/infection or severe deformity affecting laser scanning; 5. (Prospective) Contraindications to WBCT. 6. (Retrospective) Poor image quality (such as excessive loss of toes and heels); 7. (Retrospective) Metabolic bone disease or tumor affecting foot bone structure.

Design outcomes

Primary

MeasureTime frame
Concordance Correlation Coefficient (CCC);Area Under the Curve (AUC);WBCT-related Adverse Event Rate;

Countries

China

Contacts

Public ContactXin Ma

Shanghai Sixth People’s Hospital

maxin@sh163.net+86 21 52888007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026