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Contact Information:

Prof Frances Game
+44 (0)1332 783283
frances.game@nhs.net


Prof Frances Game
+44 (0)1332 783283
frances.game@nhs.net


Prof Stephen Morgan
+44 (0)115 9515570
steve.morgan@nottingham.ac.uk


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Be Part of Research - Trial Details - Monitoring wound status using multi-parameter optical fibre sensors
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Monitoring wound status using multi-parameter optical fibre sensors

Not Recruiting

Open to: All Genders

Age: Adult

Derby Derby Derby

Medical Conditions

Diabetic foot ulcer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


It is estimated that 10% of people with diabetes will have a diabetic foot ulcer at some point in their lives. In general, only half of all foot ulcers in patients with diabetes will heal in 6 months. At the moment, the assessment of possible ulcer infection and checking the ulcer is healing properly can only be assessed at a clinical appointment with a healthcare professional.
If, however, we could easily monitor an ulcer away from a clinic setting it could notify the patient and clinician that either the ulcer is not healing or has become infected between clinical appointments. This alert could mean that clinicians could intervene earlier with the treatment of infection. But equally, if the ulcer is healing well, means that routine clinic appointments just for checking could be reduced.
This study is a preliminary study to see if a new type of ulcer sensor, which is made of very fine fibres (optical fibre sensors) and built into a standard dressing, can measure chemicals and gases that may be associated with ulcer healing and infection. Although the ultimate aim will be to monitor ulcers at home, in this first stage the researchers need to see whether these fibres do in fact measure what they think they should whilst on an ulcer. So, this study will take place in the diabetic foot clinic.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Apr 2023 31 Jan 2024

The following will be conducted in addition to standard care. The OFSSWM optical probe and a sterile dressing will be placed on the largest eligible wound for up to 60 minutes. The optical probe will measure humidity, temperature, ammonia, and carbon dioxide. These will be compared with measurements from commercially available conventional sensors. Readings will be taken supine with both OFSSWM and conventional sensors. As a control, conventional measurements will also be taken in the supine position on an area of intact skin. The study will take place over an 8-week period per patient. During this time, the participants will have fortnightly visits until week 8, unless their ulcer heals before that.


Patients aged 18 years and over with diabetes and foot ulcers from the University Hospitals of Derby and Burton NHS Foundation Trust Diabetic Foot Clinic

You can take part if:



You may not be able to take part if:


1. Planned revascularisation during the course of the study or within the 4 weeks preceding the start of the study2. An ulcer of aetiology other than diabetes3. Depth of ulcer to bone, suspected or confirmed osteomyelitis4. Severe infection of the index ulcer in accordance with Infectious Diseases Society of America (IDSA) criteria5. Active Charcot of the foot of the index ulcer6. The need for negative pressure wound therapy7. Unwilling or unable to give written informed consent8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, may influence the result of the trial or the participant’s ability to participate in the trial9. Wound located on the toes or between the toes10. Wounds in a severe condition e.g. necrotic tissue and/or bleeding wounds


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Derby Hospital (nuh)
    Uttoxeter Road
    Derby
    DE22 3NE
  • University Hospitals of Derby and Burton NHS Foundation Trust (UHDB) secondary care diabetic foot multidisciplinary clinic
    Florence Nightingale Community Hospital London Road
    Derby
    DE1 2QY
  • London Road Community Hospital
    Community Building London Road Community Hospital London Road
    Derby
    DE1 2QY

Monitoring wound status remotely with optical fibre sensing will notify the patient and clinician when the wound is in an adverse state, either wound healing is not progressing or the wound is infected. This will enable clinical interventions to take place promptly but only when required, thus improving wound care and reducing the number of NHS appointments. For example, if monitoring indicates that wound healing is progressing well then this will reduce the need for specialist review and can reduce the frequency of dressing changes. On the other hand, if the wound status deteriorates rapidly, e.g. due to infection, then this will trigger an urgent specialist review, which will lead to improved outcomes, e.g., reduced admissions and amputations.
Cost savings can be made by monitoring wound status. Stratification of different wound categories (e.g. identifying wounds that are difficult to heal) will make an even more compelling case for the technology. Better wound care will result in reduced time to healing and therefore reduction in costs across all areas of diabetic foot ulcer management simply because patients will spend less time being treated.
Although there will be a higher unit cost associated with the disposable sensorised dressing and reusable electronic unit (~£4 - £9 per use compared to £2 average for current dressings), the researchers believe that this will be offset by fewer dressing changes and reduced time to healing. There will also be additional savings due to an anticipated reduction in hospital, GP and home visits and a reduced number of amputations. The device will indicate the most appropriate time to change the dressing and whether intervention is required (e.g. due to infection). A 10% reduction in costs associated with visits and admissions categories would provide a £300m annual saving to the NHS. The final product would initially concentrate on those most at risk of a non-healing wound before applying the technology to a wider population of those with chronic wounds.
Although this is the first time sensors have been applied to diabetic foot ulcers, the researchers think that any risk from the monitoring equipment is very low as the equipment has all had an independent safety review and been passed as safe.

Prof Frances Game
+44 (0)1332 783283
frances.game@nhs.net


Prof Frances Game
+44 (0)1332 783283
frances.game@nhs.net


Prof Stephen Morgan
+44 (0)115 9515570
steve.morgan@nottingham.ac.uk



The study is sponsored by University of Nottingham and funded by Medical Research Council.




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Read full details for Trial ID: ISRCTN43662626

Or CPMS 49746

Last updated 21 March 2025

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