Monitoring wound status using multi-parameter optical fibre sensors
| ISRCTN | ISRCTN43662626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43662626 |
| IRAS number | 291141 |
| Secondary identifying numbers | IRAS 291141, CPMS 49746 |
- Submission date
- 18/05/2023
- Registration date
- 30/05/2023
- Last edited
- 21/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
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.
Who can participate?
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
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
University Hospitals of Derby and Burton NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2021 to March 2024
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
For further information please contact the diabetic foot research team on +44 (0)7384871088 or email dhft.footres@nhs.net
Contact information
Principal Investigator
Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
 ORCID ID |
0000-0002-5294-4789 |
|---|---|
| Phone | +44 (0)1332 783283 |
| frances.game@nhs.net |
Scientific
University Park
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
| ORCID ID |
0000-0003-4069-3801 |
|---|---|
| Phone | +44 (0)115 9515570 |
| steve.morgan@nottingham.ac.uk |
Public
Royal Derby Hospital
University Hospitals of Derby and Burton NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
| Phone | +44 (0)1332 783283 |
|---|---|
| frances.game@nhs.net |
Study information
| Study design | Single-centre prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 43683_PIS_V4.0_01Nov22.pdf |
| Scientific title | Monitoring diabetic foot ulcer status using the Optical Fibre Sensing System for Wound Monitoring (OFSSWM) |
| Study acronym | OFSSWM |
| Study objectives | To explore the feasibility of using the Optical Fibre Sensing System for Wound Monitoring (OFSSWM) in a clinical environment. |
| Ethics approval(s) | Approved 08/09/2021, South East Scotland Research Ethics Committee 02 (2nd Floor, Waverly Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5473; Ruth.Fraser4@nhslothian.scot.nhs.uk), ref: 21/SS/0050 |
| Health condition(s) or problem(s) studied | Diabetic foot ulcer |
| Intervention | Participants will be seen at their usual clinical setting within the UHDB diabetic foot clinic. Participants will first receive all usual best patient care including local debridement and a temporary dressing if required. The following will be conducted in addition to standard care. The OFSSWM optical probe and sterile dressing will be placed on 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 in a supine position with both OFSSWM and conventional sensors. As a control, conventional measurements will also be taken in a supine position on an intact skin area. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Device: Optical Fibre Sensing System for Wound Monitoring (OFSSWM) |
| Primary outcome measure | 1. Number of participants screened/consented and reasons for not participating, measured using participant consent forms at the start of each patient visit 2. Feasibility of taking measurements for each optical probe parameter (temperature, relative humidity, ammonia, and carbon dioxide) from a wound, measured using internal algorithms for data analysis and comparison with commercial measurement devices after each patient visit. The data collected will only be used to ascertain device performance and it will not be used to alter the normal care pathway of the patient. 3. Patient feedback about the use of the optical probe, collected using a survey at the end of patient participation in the study |
| Secondary outcome measures | 1. Wound size measured as per normal clinical care with a Silhouette wound assessment camera (Entec Health Ltd) at the start of each patient visit 2. Incidence of secondary infection measured using baseline assessments as per the clinical protocol, e.g. assessment of ulcer infection by IDSA criteria (0 = none, 1 = mild [limited to skin and subcutaneous tissues and with inflammation limited to within 2cm of wound margin], 2 = moderate [deeper and/or with more extensive inflammation] and 3 = severe [with systemic symptoms and signs]) at the start of each patient visit 3. Pain in the area of the ulcer assessed by patient-completed 100 mm Visual Analogue Scale (VAS) at the start of each patient visit |
| Overall study start date | 10/05/2021 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Patients with diabetes (according to WHO criteria) aged 18 years or over 2. At least one full-thickness ulcer below the malleolus of either foot, present for 4 weeks or more 3. Ulcer located on the sole or dorsum of the foot 4. No presence of wound necrosis, significant oedema or poor tissue viability that in the opinion of the investigator may be at risk of deterioration with the use of OFSSWM optical probe 5. At least one palpable pulse on the foot of the index limb or an Association of the British Pharmaceutical Industry (ABPI) >0.9 6. Minimum ulcer diameter of 3 mm and maximum of 35 mm 7. Able to attend clinic for four separate visits 8. Estimated glomerular filtration rate (eGFR) >20 and not receiving dialysis |
| Key exclusion criteria | 1. Planned revascularisation during the course of the study or within the 4 weeks preceding the start of the study 2. An ulcer of aetiology other than diabetes 3. Depth of ulcer to bone, suspected or confirmed osteomyelitis 4. Severe infection of the index ulcer in accordance with Infectious Diseases Society of America (IDSA) criteria 5. Active Charcot of the foot of the index ulcer 6. The need for negative pressure wound therapy 7. Unwilling or unable to give written informed consent 8. 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 trial 9. Wound located on the toes or between the toes 10. Wounds in a severe condition e.g. necrotic tissue and/or bleeding wounds |
| Date of first enrolment | 18/04/2023 |
| Date of final enrolment | 31/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London Road
Derby
DE1 2QY
United Kingdom
Derby
DE22 3NE
United Kingdom
London Road Community Hospital
London Road
Derby
DE1 2QY
United Kingdom
Sponsor information
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Phone | +44 (0)1158467906 |
|---|---|
| angela.shone@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 20/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The researchers will target major conferences such as Photonics West, IEEE Sensors, the American Diabetes Association and the European Association for the Study of Diabetes and leading journals such as Nature Biomedical Engineering, Biosensors and Bioelectronics, Lancet Diabetes and Endocrinology, Diabetes Care and Diabetologia. The researchers will ensure the user group convened to support development is updated via an email newsletter. They will participate in public engagement events organised by UoN such as ‘Wonder’. In all cases study participants will not be identifiable. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. Once sufficient commercialisation progress has been made and intellectual property is protected, the researchers will make raw data available through the University of Nottingham Research Data Repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 24/05/2023 | No | No | ||
| Participant information sheet | version 4.0 | 01/11/2022 | 24/05/2023 | No | Yes |
| Protocol file | version 4.1 | 28/03/2023 | 24/05/2023 | No | No |
| Protocol file | version 4.3 | 20/11/2023 | 11/03/2024 | No | No |
| Basic results | 21/03/2025 | No | No | ||
| Statistical Analysis Plan | version .06 | 16/09/2024 | 21/03/2025 | No | No |
Additional files
Editorial Notes
21/03/2025: Basic results and statistical analysis plan added.
12/09/2024: The intention to publish date was changed from 30/09/2024 to 20/03/2025.
11/03/2024: The following changes were made to the study record:
1. Total final enrolment added.
2. The intention to publish date was changed from 31/03/2024 to 30/09/2024.
3. Protocol uploaded.
11/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2023 to 31/01/2024.
2. The overall end date was changed from 31/08/2023 to 31/03/2024.
3. The intention to publish date was changed from 31/08/2024 to 31/03/2024.
4. The plain English summary was updated to reflect these changes.
05/06/2023: Internal review.
24/05/2023: Study's existence confirmed by South East Scotland Research Ethics Committee 02.
