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A study for the prevention of diabetic foot ulcers

Research on AI-assisted plantar temperature monitoring and image recognition system in preventing the occurrence of diabetic foot ulcers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094180
Enrollment
Unknown
Registered
2024-12-18
Start date
2025-03-27
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Diabetic foot

Interventions

Healthy subject group:NA
Strengthen the management group(Personalized diabetes education management + AI-assisted plantar temperature and pressure image recognition system):Provide patients with wearable devices that match th
Routine management group (personalized diabetes education management + infrared thermometer monitoring of foot temperature):Patients are provided with infrared temperature monitors to monitor the temp

Sponsors

The Ninth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Part I Inclusion Criteria: 1) Healthy participants aged 18 to 80; 2) Able to walk on a daily basis ; 3) Subject is willing and able to sign the informed consent form. Part II Inclusion Criteria: 1) Patients with type 1 or type 2 diabetes who are >= 18 years old and = grade 2 patients: grade 2 refers to both sensory neuropathy and peripheral vascular disease or sensory neuropathy + foot deformity or peripheral vascular disease + foot deformity; Grade 3, with sensory neuropathy or peripheral vascular disease plus any of the following: history of foot ulcer, history of lower extremity amputation, end-stage renal disease. 3) Able to walk on a daily basis; 4) Subject is willing and able to sign the informed consent form.

Exclusion criteria

Exclusion criteria: Part 1 Exclusion Criteria: Subjects who cannot express exactly. Part II Exclusion Criteria: 1) Patients who are currently suffering from diabetic foot ulcers; 2) Patients with ischemia who are chronically limb threatening; 3) The acute phase of Charcot's arthropathy; 4) Patients with proximal bilateral amputation of the metatarsal joint; 5) Unstable cardiovascular and cerebrovascular diseases; 6) Patients with mental illness or lack of self-awareness who cannot express themselves accurately.

Design outcomes

Primary

MeasureTime frame
Plantar temperature;Plantar pressure image;Incidence of diabetic foot ulcers;Recurrence rate of diabetic foot ulcers;

Secondary

MeasureTime frame
AOFAS Ankle-Hindfoot Rating Scale;VAS Pain Assessment Scale;EQ-5D Health Index Scale;WHO Happiness Index Scale;

Countries

China

Contacts

Public ContactAihong Wang

The Ninth Medical Center of PLA General Hospital

13671365441@139.com+86 136 7136 5441

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026