Effectiveness of podiatry to prevent foot ulcers in diabetic patients with polyneuropathy

Completed

• Conditions: Diabetic foot; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN50646165
• Lead Sponsor: niversity Maastricht (UM) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 562

Inclusion Criteria

1. Patients aged over 18 years, either sex
2. Diabetes mellitus
3. Signs of peripheral polyneuropathy. Polyneuropathy is defined as absence of pressure sensation (10 gram Semmes Weinstein monofilament) and/or absence of the vibration perception sense (128 Hertz tuning fork).

Exclusion Criteria

1. Polyneuropathy not related to diabetes
2. Type 1 diabetes with a duration less than 10 years
3. An active foot ulcer or a healed ulcer in the past year
4. Severe peripheral arterial disease (ankle pressure less than 50 mmHg measured with a hand held Doppler)
5. Foot surgery or peripheral bypass surgery during the past year
6. Rheumatoid disease and renal replacement therapy
7. Patients should not have consulted a podiatrist in the past year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Development of a foot ulcer during the 3-year follow-up period<br>2. Number of ulcer related procedures in the 3-month period after the first detection of an ulcer

Secondary Outcome Measures

Name	Time	Method
1. Severity of the ulcer<br>2. Healing time<br>3. Major interventions<br>4. Hospitalisation days related to ulceration<br><br>Measured at the onset of ulceration and after 3 month after onset of ulceration.