Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/04/2010
Date assigned
10/06/2010
Last edited
10/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Margreet van Putten

ORCID ID

Contact details

mgr.Witloxweg 22
Eindhoven
5624JH
Netherlands
+31 (0)62 097 1135
m.vanputten01@chello.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Podoproof trial

Study hypothesis

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

Ethics board of Academic Hospital Maastricht (azM)/Maastricht University Medical Centre (MUMC) approved on the 15th November 1996 (ref: AZM00230014/151196)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

09/09/1996

Overall trial end date

01/05/2002

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

281 patients per study group (562 in total)

Participant 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

Recruitment start date

09/09/1996

Recruitment end date

01/05/2002

Locations

Countries of recruitment

Netherlands

Trial participating centre

mgr.Witloxweg 22
Eindhoven
5624JH
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (The Netherlands)

Sponsor details

Division Endocrinology
Department Internal Medicine
MUMC+
PO Box 616
Maastricht
6200MD
Netherlands
+31 (0)43 388 2222
m.vanputten01@chello.nl

Sponsor type

University/education

Website

http://www.maastrichtuniversity.nl

Funders

Funder type

University/education

Funder name

Dutch Health Insurance Council (College van Zorgverzekeraars [CVZ]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fontys University of Applied Sciences (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Maastricht University Medical Centre (Netherlands) - Division of Endocrinology Department of Internal Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes