Monitoring foot health in patients with Diabetes: a prospective study

The clinical evolution of feet in Diabetic patients: a prospective study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

REBEC

Registry ID

RBR-4t5vhzp

Enrollment

280

Registered

2026-06-24

Start date

2026-02-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Surgical amputation

Interventions

Observational study involving 280 patients, aimed at identifying the occurrence of lower-limb amputation in patients with diabetic foot and its association with the clinical and vascular severity of t

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with diabetic foot who are diagnosed and/or treated at the Vascular Surgery Department of Casa de Saúde Santa Marcelina during the study period; both sexes; minimum age of 18 years.

Exclusion criteria

Exclusion criteria: atients who previously underwent lower limb revascularization; patients with major amputations; bedridden patients following a stroke (cerebrovascular accident, CVA); patients with neurological sequelae affecting the lower limbs; and patients lost to clinical follow-up

Design outcomes

Primary

Measure	Time frame
It is expected to identify the occurrence of lower-limb amputation in patients with diabetic foot and its association with the clinical and vascular severity of the disease, assessed using the Rutherford, WIfI, and GLASS classification systems, together with clinical follow-up during hospitalization, outpatient monitoring, and up to six months after completion of treatment. The outcome will be evaluated by the frequency and proportion of patients who progress to minor or major amputation, as well as by comparing these rates across different clinical, infectious, and vascular anatomical risk strata.	—

Measure

Time frame

It is expected to identify the occurrence of lower-limb amputation in patients with diabetic foot and its association with the clinical and vascular severity of the disease, assessed using the Rutherford, WIfI, and GLASS classification systems, together with clinical follow-up during hospitalization, outpatient monitoring, and up to six months after completion of treatment. The outcome will be evaluated by the frequency and proportion of patients who progress to minor or major amputation, as well as by comparing these rates across different clinical, infectious, and vascular anatomical risk strata.

—

Secondary

Measure	Time frame
No secondary outcomes are expected	—

Countries

Contacts

Public ContactOsvaldo Júnior

Universidade Federal de São Paulo - UNIFESP

osvaldo.pelozo@santamarcelina.edu.br+55(11)3385-4343 - ramal: 2653 ou 2655

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026