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

• Conditions: Diabetes; Diabetic foot; 10012653; 10034606

• Registration Number: NL-OMON30851
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

1. Age >18 and <85 years old
2. Diagnosis of diabetes mellitus Type 1 or 2
3. Loss of protective sensation due to peripheral neuropathy
4. A history of plantar foot ulceration within the last 18 months
5. A new therapeutic footwear prescription (OSA or OSB)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients with a recurrent plantar foot ulcer in 18 months </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Cost-effectiveness and const-utility of using in-shoe plantar pressure<br /><br>analysis<br /><br>- Perceive usability of therapeutic footwear<br /><br>- Compliance of shoe use<br /><br>- Daily activity level </p><br>