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Reliability and construct validity of pressure measurement systems in neuropathic diabetic patients

Reliability and construct validity of pressure measurement systems in neuropathic diabetic patients - Reliability & validity FootWork Pro diabetic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54952
Enrollment
60
Registered
2020-10-21
Start date
2021-07-21
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

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Presence of diabetic peripheral neuropathy, indicated by insensitivity to a 10 g Semmes-Weinstein Monofilament for at least two out of three times at the hallux, first metatarsal head or fifth metatarsal head.

Exclusion criteria

Exclusion criteria: Unable to walk or stand (barefoot) Use a walking aid Current foot ulcer Bilaterale amputation proximal to the metatarsals Non-diabetic neurological deficit

Design outcomes

Primary

MeasureTime frame
Intra-class correlation coefficients of several pressure measurement parameters

Secondary

MeasureTime frame
The degree to which the scores of the FootWork Pro PMS are consistent with a priori formulated theoretical hypotheses (construct validity).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)