Effectiveness of local pressure reduction in different shoes for diabetic patients characterized by flexible and stiff sole constructions.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003205

Enrollment

Registered

2011-12-20

Start date

2011-11-21

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E11.74 E10.74

Interventions

Group 1: Rigid sole - shoe type 1 - three different widths - outsole of EVA and rubber (Softrubber) - soft upper (cloth, foam, leather) without a toe cup - soft insole for diabetic patients with 3 la

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with diabetes mellitus and the risk class II or III, which should be supplied with a diabetic protection shoe with a removable soft orthotic and, if required with orthopedic technical shoe modifications. Risk class II (Loss of sensation, due to polyneuropathy or peripherial vascular disease) Risk class III (ulcer in the history)

Exclusion criteria

Exclusion criteria: Footdeformity requiring a custom made shoe. Open ulcer, gangren.

Design outcomes

Primary

Measure	Time frame
Static and dynamic pressure analysis - barefoot and as insole investigation in the different type of shoes (peak pressure and average pressure) Measuring system: T&T medilogic Medizintechnik GmbH, Mittelstrasse 9 D-12529 Schönefeld	—

Countries

Germany

Contacts

Public ContactArthur Grünerbel

Diabetische Schwerpunktpraxis

arthur@gruenerbel.de+49 89 791 7818

Outcome results

None listed

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