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A multi-center study of implementation of multidisciplinary closed-loop management and high risk foot screening to improve the prognosis and health economic burden of high-risk diabetic foot

A multi-center study of implementation of multidisciplinary closed-loop management and high risk foot screening to improve the prognosis and health economic burden of high-risk diabetic foot

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051856
Enrollment
Unknown
Registered
2021-10-07
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Diabetic foot and high risk foot

Interventions

Control group:Diagnosis and treatment mode based on patient's own wishes

Sponsors

Jinshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years, no gender limit; 2. Diabetes has been diagnosed; 3. According to the IWGDF2019 standard, it is determined as a high-risk foot, which meets any of the following: (1) Loss of protective neurosensory (LOPS) or peripheral vascular disease (PAD); (2) Suffering from both LOPS and PAD, or LOPS combined with foot deformity, or PAD combined with foot deformity; (3) Suffering from LOPS or PAD, and a history of foot ulcer, lower limb amputation/toe amputation, or end-stage renal disease (Among them, foot deformities include, but are not limited to, valgus valgus, varus little toe, claw toe, hammer toe, hammer toe and other toe deformities, arch deformities, etc. Peripheral vascular disease refers to ankle-brachial index (ABI) 1.3, and vascular ultrasound initially confirmed lower extremity arterial stenosis/occlusion. Loss of protective sensory function in LOPS using the 10 g nylon wire test or the 128 Hz tuning fork test. ); 4. Have complete personal baseline information; 5. The informed consent has been signed.

Exclusion criteria

Exclusion criteria: 1. Combined with severe heart, lung and liver failure; 2. History of malignant tumor and in active stage; 3. Life expectancy is less than 2 years; 4. Unable to complete or tolerate the examination and treatment during the intervention; 5. Inability to provide complete medical history information; 6. Currently receiving multidisciplinary or specialized diagnosis and treatment related to diabetic foot in other secondary or tertiary medical centers; 7. Participating in diabetes-related clinical trials.

Design outcomes

Primary

MeasureTime frame
Diabetic foot-free survival;Amputation-free survival;

Secondary

MeasureTime frame
High risk foot grade;Life quality score;

Countries

China

Contacts

Public ContactDong Zhihui

Zhongshan Hospital Affiliated to Fudan University, Jinshan Hospital Affiliated to Fudan University

dzh926@126.com+86 13564249168

Outcome results

None listed

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