Effectiveness of podiatry to prevent foot ulcers in diabetic patients with polyneuropathy
| ISRCTN | ISRCTN50646165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50646165 |
| Secondary identifying numbers | N/A |
- 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
Scientific
mgr.Witloxweg 22
Eindhoven
5624JH
Netherlands
| Phone | +31 (0)62 097 1135 |
|---|---|
| m.vanputten01@chello.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 09/09/1996 |
| Completion date | 01/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 281 patients per study group (562 in total) |
| 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
5624JH
Netherlands
Sponsor information
University Maastricht (UM) (The Netherlands)
University/education
University/education
Division Endocrinology
Department Internal Medicine, MUMC+
PO Box 616
Maastricht
6200MD
Netherlands
| Phone | +31 (0)43 388 2222 |
|---|---|
| m.vanputten01@chello.nl | |
| Website | http://www.maastrichtuniversity.nl |
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
University/education
Dutch Health Insurance Council (College van Zorgverzekeraars [CVZ]) (Netherlands)
No information available
Fontys University of Applied Sciences (Netherlands)
No information available
Maastricht University Medical Centre (Netherlands) - Division of Endocrinology Department of Internal Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
