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Effect of insole top covers on pressure relief and satisfaction in patients with diabetes

Effect of insole top covers on pressure relief and satisfaction in patients with diabetes - DIATOP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55590
Enrollment
20
Registered
2019-11-07
Start date
2019-12-09
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

Diabetic foot diabetic neuropathy

Interventions

The patients left and right insole will be covered with two different and randomly assigned insole top covers that were tested, and wear these for approximately 4 weeks. This will be repeated with t

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diabetes mellitus - Peripheral neuropathy - Diabetic foot risk classification categories 2 and 3 (i.e. presence of peripheral vascular disease or foot deformity, or a history of foot ulceration). - Possession of or prescription of semi-custom-made or fully custom-made footwear

Exclusion criteria

Exclusion criteria: - Active ulceration - Inability to walk at least 100m - Amputation of more than 2 toes (not the hallux)

Design outcomes

Primary

MeasureTime frame
Peak plantar pressure

Secondary

MeasureTime frame
Patient satisfaction In-vivo durability of insole top layer material

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)