Evaluation of optical imaging in foot ulcer management
| ISRCTN | ISRCTN50978600 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50978600 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 331195 |
| Protocol serial number | CPMS 68419, IRAS 331195 |
| Sponsor | University of Surrey |
| Funders | iThera, Medical Research Council, European Association of National Metrology Institutes, UK Research and Innovation |
- Submission date
- 07/06/2024
- Registration date
- 19/07/2024
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Non-healing foot wounds (ulcers) are frequent and lead to poor quality-of-life with high risk of amputation and mortality. A major reason for wounds not to heal are blocked arteries in the legs. Currently, the standard test to measure the blood flow in the legs is called ankle brachial pressure index (ABPI) and it requires blood pressure measurement with a cuff at the ankle. However, ABPI is not frequently performed, may miss diagnoses, and does not measure blood flow in the foot where ulcers are.
Optoacoustic imaging (OAI) and photoplethysmography (PPG) are 2 new non-invasive methods that can use light to measure oxygen and blood flow through the skin, but these have not been tested in patients with ulcers.
The aim of the study is to evaluate the value of OAI and PPG in patients with foot ulcers. We hypothesize that OAI and PPG can provide additional important clinical information otherwise not available.
Who can participate?
All patients with foot ulcers scheduled for routine appointments in the multidisciplinary diabetic foot and vascular clinics at East Surrey Hospital.
What does the study involve?
OAI and PPG scans will be performed at several sites along the leg and foot in addition to standard investigations. In those patients that will undergo surgery to improve blood flow as part of usual care, we will repeat all measurements after surgery. We will collect the results of the standard investigations and baseline medical and sociodemographic characteristics and collect 1 year outcome data based on electronic patient records.
What are the possible benefits and risks of participating?
There are no direct benefits to patients. The results will help vascular doctors to evaluate the value of OAI and PPG and if they can provide additional important clinical information otherwise not available.
Where is the study run from?
East Surrey Hospital (Surrey and Sussex Healthcare NHS Trust), Redhill with the University of Surrey (Department of Clinical and Experimental Medicine), Guildford (UK)
When is the study starting and how long is it expected to run for?
December 2023 to March 2026
Who is funding the study?
The study is funded by iThera Medical and Medical Research Council (UK)
Who is the main contact?
Prof. Christian Heiss, c.heiss@surrey.ac.uk
Contact information
Public, Scientific, Principal investigator
University of Surrey
Leggett building
Guildford
GU2 7XH
United Kingdom
 ORCID ID |
0000-0002-3212-8995 |
|---|---|
| Phone | +44 (0)1483 686693 |
| c.heiss@surrey.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre prospective observational cross-sectional pilot study |
| Secondary study design | Cross sectional study |
| Participant information sheet | 45586 PIS V01 12-06-2024.pdf |
| Scientific title | Evaluation of optoacoustic imaging and photoplethysmography in patients with foot ulcers: a cross-sectional pilot study |
| Study acronym | OAI-1 |
| Study objectives | Optoacoustic imaging (OAI) and photoplethysmography (PPG) can provide additional important clinical information that is otherwise not available. |
| Ethics approval(s) |
Approved 10/07/2024, South Central - Oxford C Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8271; oxfordc.rec@hra.nhs.uk), ref: 24/SC/0242 |
| Health condition(s) or problem(s) studied | Foot ulcers |
| Intervention | Patients with ulcers will be prospectively recruited in the multidisciplinary diabetic foot and vascular clinics. Optoacoustic imaging (OAI) and photoplethysmography (PPG) scans will be performed at several sites along the leg and foot in addition to standard investigations (ultrasound, ABPI, toe pressure) and baseline medical and sociodemographic characteristics. Some patients will undergo surgery to improve blood flow as part of usual care. In these patients, the researchers will repeat all measurements after surgery. They will collect 1 year outcome data (wound healing, amputation, mortality) based on electronic patient records. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Tissue oxygenation and blood flow measured using optoacoustic imaging in feet at baseline (all) and after angioplasty (subgroup that receives angioplasty as standard of care) |
| Key secondary outcome measure(s) |
1. Ankle brachial pressure index measured using ankle Doppler based estimated ABPI (eABPI) at baseline and after angioplasty (subgroup) |
| Completion date | 01/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Age 18 years or greater 2. Non-healing foot wound for at least 4 weeks despite wound care 3. Scheduled for/referred to routine vascular assessment, multidisciplinary foot team clinic or endovascular revascularisation 4. Willing and able to provide informed consent 5. Vascular ultrasound exam required including Ankle Brachial Pressure Index (ABPI) and Toe Brachial Index (TBI) |
| Key exclusion criteria | 1. Heart failure New York Heart Association (NYHA) ≥3 2. Systemic inflammation 3. Critically ill, American Society of Anesthesiologists (ASA) IV 4. Extensive foot wounds making OAI scanning impossible 5. No toes to measure TBI 6. Leg wounds or skin conditions preventing ABPI, OAI or ultrasound investigations 7. Participants who are unable to wear the laser safety goggles 8. Tattoos in the field of view for OAI scanner 9. Currently under phototherapy 10. History of photosensitising disease (e.g. porphyria, Lupus erythematosus) 11. Experiencing photo-toxicity associated with currently taking or having taken photosensitizing agents within the previous 72 h (e.g. sulfonamides, ampicillin, tetracycline, doxycycline) 12. Pregnancy |
| Date of first enrolment | 18/12/2024 |
| Date of final enrolment | 31/03/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 01 | 12/06/2024 | 12/07/2024 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 45586 PIS V01 12-06-2024.pdf
- Participant information sheet
Editorial Notes
20/01/2025: The recruitment end date was changed from 01/02/2025 to 31/03/2025.
17/01/2025: The recruitment start date was changed from 01/09/2024 to 18/12/2024.
19/07/2024: The recruitment start date was changed from 01/07/2024 to 01/09/2024.
12/07/2024: Trial's existence confirmed by South Central - Oxford C Research Ethics Committee.
