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Implementation of multidisciplinary closed-loop management strategy to improve the prognosis of high-riskfoot related to diabetic mellitus: a prospective, multicenter, cluster randomized controlled trial

Implementation of multidisciplinary closed-loop management strategy to improve the prognosis of high-riskfoot related to diabetic mellitus: a prospective, multicenter, cluster randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090828
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-10-30
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Diabeitc foot disease

Interventions

Control group:Diagnosis and treatment mode based on patients own wishes

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Male or female over 18 years old; (2) Diagnosed with diabetes; (3) Identified as high-risk foot according to the IWGDF 2019 criteria, meeting any of the following: 1) Loss of protective sensation (LOPS) or peripheral arterial disease (PAD) 2) Both LOPS and PAD, or LOPS combined with foot deformity, or PAD combined with foot deformity 3) LOPS or PAD, and a history of foot ulcers, lower limb amputation/toe amputation, or end-stage renal disease. *Foot deformities include but are not limited to hallux valgus, little toe varus, claw toe, hammer toe, mallet toe, and other toe deformities, as well as arch deformities. Peripheral arterial disease refers to an ankle-brachial index (ABI) 1.3, with preliminary confirmation of lower extremity arterial stenosis/occlusion by vascular ultrasound. The 10g monofilament test or 128Hz tuning fork test indicates a loss of protective sensation (LOPS). (4) Has complete personal baseline data; (5) Has signed informed consent.

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
occurence ;

Secondary

MeasureTime frame
major amputation;minor amputation;toe amputation;death;Grade At-risk foot ;

Countries

China

Contacts

Public ContactZhihui Dong

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

dzh926@126.com+86 135 6424 9168

Outcome results

None listed

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