The effectiveness of plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration in diabetic patients: a randomised controlled trial

The effectiveness of plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration in diabetic patients: a randomised controlled trial - DIAFOS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30851

Enrollment

240

Registered

2007-09-25

Start date

2007-07-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Diabetes Diabetic foot

Interventions

The intervention consists of the 3-monthly use of in-shoe pressure analysis for the optimization of therapeutic footwear in diabetic patients with a prior plantar foot ulcer.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >18 and

Exclusion criteria

Exclusion criteria: 1. Active foot ulceration 2. Amputation proximal to the metatarsal bones in the foot 3. Severe illness that would make 18-months survival unlikely 4. The use of walking aids that contribute to offloading the foot (wheel chair, more than one crutch) 5. Parallel participation in another study that may influence the outcomes of this study. 6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with a recurrent plantar foot ulcer in 18 months	—

Secondary

Measure	Time frame
- Cost-effectiveness and const-utility of using in-shoe plantar pressure analysis - Perceive usability of therapeutic footwear - Compliance of shoe use - Daily activity level	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)