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

The effectiveness of preventive podiatric care versus treatment as usual to reduce the number of foot ulcers in diabetic patients with polyneuropathy: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50646165
Enrollment
562
Registered
2010-06-10
Start date
1996-09-09
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Diabetic foot Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

After randomisation, patients in the intervention group made an appointment with a participating local podiatrist within 2 weeks. These podiatrists (n = 20) were alumni of the School for Podiatry in E

Sponsors

University Maastricht (UM) (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Development of a foot ulcer during the 3-year follow-up period 2. Number of ulcer related procedures in the 3-month period after the first detection of an ulcer

Secondary

MeasureTime frame
1. Severity of the ulcer 2. Healing time 3. Major interventions 4. Hospitalisation days related to ulceration Measured at the onset of ulceration and after 3 month after onset of ulceration.

Countries

Netherlands

Outcome results

None listed

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