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

ISRCTN	ISRCTN50646165
DOI	https://doi.org/10.1186/ISRCTN50646165
Protocol serial number	N/A
Sponsor	University Maastricht (UM) (The Netherlands)
Funders	Dutch Health Insurance Council (College van Zorgverzekeraars [CVZ]) (Netherlands), Fontys University of Applied Sciences (Netherlands), Maastricht University Medical Centre (Netherlands) - Division of Endocrinology Department of Internal Medicine

Submission date: 21/04/2010
Registration date: 10/06/2010
Last edited: 10/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Margreet van Putten
Scientific

mgr.Witloxweg 22
Eindhoven
5624JH
Netherlands

Phone	+31 (0)62 097 1135
Email	m.vanputten01@chello.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	Podoproof trial
Study objectives	The aim of the study was to determine whether preventive podiatric care reduces the number of foot ulcers or results in less severe ulcers in diabetic patients with polyneuropathy and no recent history of foot ulceration or severe foot deformities. Secondary endpoints for the study included markers of ulcer severity such as the number of hospitalisation days for a foot ulcer, the number of surgical or invasive vascular procedures and the number of days until an ulcer was healed.
Ethics approval(s)	Ethics board of Academic Hospital Maastricht (azM)/Maastricht University Medical Centre (MUMC) approved on the 15th November 1996 (ref: AZM00230014/151196)
Health condition(s) or problem(s) studied	Diabetic foot
Intervention	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 Eindhoven, the Netherlands and were trained additionally for the purpose of this study. Subjects were instructed to visit the podiatrist for examination and treatment of their feet twice a year or more often as needed during the 3 year study period. Podiatric care included removal of callus, trimming nails, application of nail braces, prescribing insoles, orthotic toe devices and other off-loading techniques as well as shoe adjustments. Moreover, education and advice about foot care and shoe wear were given at each visit. Clinical findings and applied therapeutic procedures were recorded. In the control group extra podiatric consultations in case of (pre-)ulceration were allowed as well as treatment as usual. Follow-up and care for their diabetes were continued as usual for both intervention and control group patients.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/05/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	562
Key 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).
Key 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
Date of first enrolment	09/09/1996
Date of final enrolment	01/05/2002

Locations

Countries of recruitment

Netherlands

Study participating centre

mgr.Witloxweg 22

Eindhoven
5624JH
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes