Boneloss following immobilization in diabetes mellitus, an inventory using an ultrasound method (BINDEX).

Boneloss following immobilization in diabetes mellitus, an inventory using an ultrasound method (BINDEX). - Bone loss following immobilization in diabetic patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44529

Enrollment

150

Registered

2017-09-05

Start date

2017-09-18

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

diabetes Diabetes mellitus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For patients: Men and women aged > 18 years, suffering from diabetes with an indication for cast immobilization of the lower leg due to neuropathic or vascular complications.;For controls: Non-diabetic men and woman aged >18 years

Exclusion criteria

Exclusion criteria: For patients: Chronic immobilization (wheelchair-dependent), not ADL-independent, metastasized cancer, not-Dutch speaking, use of bisphosphonates

Design outcomes

Primary

Measure	Time frame
Primary outcome measures are Density Index (g / cm 2) and cortex thickness (mm) in both legs, difference in mean density index between paired legs, difference in mean cortex thickness between paired legs, difference in medians of density index between paired legs, Difference in medians of cortex thickness between paired legs.	—

Secondary

Measure	Time frame
To extract from patient records: Secondary: Number of cast treatments, total duration of cast treatments, average HbA1c, number of years suffering from diabetes. Other: Medication use, Type of Diabetes, EGFR, Degree of Neuropathy: Monofilament, Vibration. , Degree of vasculopathy: EAI, pulsations, toe pressure. Side of dominant leg.	—

Countries

Netherlands

Outcome results