Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/10/2013
Date assigned
04/10/2013
Last edited
05/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Some people with diabetes may develop a wound on their feet known as an ulcer. People with diabetes and a loss of sensation in their feet (known as peripheral neuropathy) are at particularly high risk of developing a foot ulcer because they have lost the ability to feel pain and other sensory information. Patients therefore have no means of knowing when damage is being done, leading to high pressure on the feet. We aim to use a system to measure the pressure on the feet and provide this information to a wristwatch worn by the participant. If particularly high pressures are measured on the feet, the wristwatch will alert the participant and provide information to try to reduce these pressures. By using this new technology we hope to reduce the risk of foot ulcers in people with diabetes.

Who can participate?
People over the age of 18 with diabetes, neuropathy and a previous history of foot ulcers may participate in the study, although any patients with a current foot ulcer will not be eligible. Patients must be able to walk independently for around 100 metres.

What does the study involve?
Consenting participants will be randomly allocated to one of two groups. The intervention group will wear very thin insole sensors underneath existing insoles inside their shoes which measure foot pressures. A wristwatch is also supplied which provides information to participants about high foot pressures and advice about how to reduce these pressures when they occur. The other group (the control group) will have exactly the same as the intervention group, but the wristwatch will not provide any information and advice to participants. Participants need to wear the sensors in their shoes and the wristwatch for 18 months and we will see them each month to check that the system is working properly, examine their feet to check for a foot ulcer and take some other simple measures such as the temperature of their feet. We will test participants’ feet for nerve damage at the start of the study and again after 6, 12 and 18 months. Tests to assess the blood supply to their feet will be done by measuring the blood pressure at the arm and ankle. We will repeat these tests at the beginning and end of the study.

What are the possible benefits and risks of participating?
We hope that using this system will reduce the risk of developing a foot ulcer. Also, if participants complete the study period (or leave the study due to a foot ulcer) they will be able to keep this system. They will also receive a monthly foot examination, which is in addition to the routine yearly examination. We do not expect any risks associated with taking part in this study. The only small possible risk is that by looking at the information on the wristwatch while walking participants may become distracted, which may increase the risk of bumping into something/somebody, or tripping over something.

Where is the study run from?
We will run the study from a number of sites in Manchester and the North West of the UK such as the Diabetes Centre at the Manchester Royal Infirmary, Chorley and South Ribble Hospital and the Manchester Metropolitan University.

When is the study starting and how long is it expected to run for?
The study is expected to start in November 2013 and is expected to run for three years.

Who is funding the study?
Diabetes UK.

Who is the main contact?
Professor Neil Reeves
N.Reeves@mmu.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Neil Reeves

ORCID ID

Contact details

IRM Research Institute
John Dalton Building
Chester Street
Manchester
M1 5GD
United Kingdom
N.Reeves@mmu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15186

Study information

Scientific title

Prevention of foot ulcer recurrence in diabetes patients using plantar pressure biofeedback: a randomised controlled trial

Acronym

Study hypothesis

The aim of this study is to prevent foot ulcers in people with diabetes and a history of foot ulceration. A system will be used that measures the pressure applied under the feet and provides information and advice to the patient if the pressure is considered to be too high. Patients with diabetes will be randomised to one of two groups: 1. an intervention group and 2. a control group. The intervention group will wear sensors in their shoes and receive information and advice on their foot pressures if they become too high. The control group will wear sensors in their shoes, but will not receive any information or advice on their foot pressures. Patients will be followed over a period of 18 months where all feet will be closely monitored for the development of an ulcer. If patients in either group develop a foot ulcer they will leave the study to be treated appropriately.

Ethics approval

13/NW/0649; First MREC approval date 17/09/2013

Study design

Randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Topic: Diabetes Research Network; Subtopic: Both; Disease: Neuropathy, Diabetic foot

Intervention

Once patients are recruited to the study they will be randomly assigned to one of two groups using random number generating software (1 - intervention or 2 - control):
1. Intervention (biofeedback) group, wearing in-shoe pressure sensors which provide feedback alerts (relating to high plantar pressures) and offloading guidance to a watch display for the prevention of a diabetic foot ulcer.
2. Control group, wearing in-shoe pressure sensors that measure foot pressures and store this information within the wristwatch, but do not provide any form of feedback to the patient.
Both groups would receive the same, unaltered standard clinical care including podiatry assessment and treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Foot ulceration. The feet will be checked for ulceration every month for 18 months.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/11/2013

Overall trial end date

30/11/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with Type 1 or 2 diabetes
2. A history of previous ulceration on the weight-bearing surface of the foot
3. Presence of neuropathy (defined by any loss of sensation)
4. Ability to walk independently for approx. 100 metres (i.e., without use of wheelchair, walking stick or personal assistance)
5. Aged >18 years
6. Able to understand all of the study requirements and have a life expectancy greater than the study duration
Target Gender: Male & Female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Active foot ulcer
2. In-shoe orthotics consisting of non-compressible materials
3. Presence of severe ischaemia for either foot defined by complete absence of foot pulses and ankle-brachial pressure index <0.6
4. Lower limb amputation affecting the ability to walk approx. 100 metres
5. Dementia, uncorrected visual or psychological impairment
6. Psychiatric illnesses or social situations that would limit compliance with the study
7. Inner ear pathology, or other serious underlying balance dysfunction
8. Significant cardiopulmonary or other systemic disease limiting the patient's ability to walk approx. 100 metres unaided
9. Current participation in another clinical investigation of a medical device or a drug, or participation in such a study within 30 days prior to study enrolment
10. Body Mass Index (BMI) >40

Recruitment start date

07/11/2013

Recruitment end date

30/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

IRM Research Institute
Manchester
M1 5GD
United Kingdom

Sponsor information

Organisation

Manchester Metropolitan University (UK)

Sponsor details

First Floor
Ormond Building
Lower Ormond Street
Manchester
M15 6BX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Diabetes UK (UK); Grant Codes: 12/0004565

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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