Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers
This study is testing a new remote monitoring system called TASHA, which uses 3D foot scans to check on diabetic foot ulcers. The main aim is to see if TASHA can provide measurements (like size and depth) that are similar to what healthcare professionals find in clinic. Researchers also want to find out if patients can successfully scan their own ulcers with the system, guided by staff. Another goal is to understand how much variation there is between scans taken by clinic staff and those taken by patients. The findings will help improve future trials and the development of TASHA as a medical device for use in the NHS.
At a glance
What is this study about?
Diabetic foot ulcers are a common and serious problem for people with diabetes. They can lead to infections, hospital stays, and sometimes even leg amputation. Keeping a close eye on these ulcers is really important to make sure they heal well and to spot any problems early, but regular clinic visits can be difficult for some people due to distance or limited appointments.
This study is looking at a new device called TASHA, which is a remote monitoring system that uses 3D scanning to create a detailed digital image of a diabetic foot ulcer. The idea is that this system could help doctors keep track of ulcers more easily and allow patients to monitor their own ulcers from home in the future. By getting clear, consistent images, doctors might be able to assess how well an ulcer is healing and make decisions about treatment without needing as many in-person visits.
This early study, called a "pilot study," is being done in an NHS clinic in the UK. It's not about checking if TASHA treats ulcers, but rather if the system itself works well. Researchers want to know if the 3D scans give accurate information about the ulcer (like its size and depth), if patients can learn to use the scanner themselves with guidance, and if the information gathered by TASHA matches what doctors see in the clinic. The results will help decide how to design bigger studies and gain approval for TASHA to be used more widely.
Key takeaways
- A study testing a new remote 3D scanning system (TASHA) for diabetic foot ulcers.
- Aims to see if TASHA can accurately measure ulcers and if patients can use it.
- Participation involves an extra 3D scan during a routine clinic visit and supervised self-scanning.
- No new medications; it's an observational feasibility study.
- Results will help design future, larger studies and develop TASHA as a medical device.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or over, who has been diagnosed with a diabetic foot ulcer and is currently receiving care at the NHS clinic involved in the study. You also need to be able to understand the study information and give your consent to take part. It's important that you can sit comfortably to use the TASHA scanning device and are willing to try scanning your own foot with help from the clinic staff.
However, you wouldn't be able to join the study if your foot ulcer isn't related to diabetes, or if you have severe memory problems or physical difficulties that would make it hard to use the scanner or follow instructions. If you have a serious infection or other urgent medical problem, or are already taking part in another clinical study that might affect this one, you also wouldn't be eligible. Lastly, if you can't communicate in English and we can't arrange suitable translation or support, then you wouldn't be able to participate.
- Are you 18 years old or older?
- Do you have a diabetic foot ulcer?
- Are you receiving care at the NHS clinic involved in this study?
- Can you understand information about the study and give your consent?
- Are you able to sit and comfortably use a scanning device?
- Are you willing to try scanning your own foot with help?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will attend a standard clinic appointment for your diabetic foot ulcer, just as you usually would. During this visit, in addition to your regular assessment, you will have an extra 3D scan of your foot ulcer using the TASHA system. You will then be guided by clinic staff on how to use the TASHA system to scan your own ulcer. Your scan data will be looked at by a doctor remotely to compare it with the assessments made in the clinic. This study is observational and involves a single clinic visit; there are no medications or special follow-up visits, so your total participation is limited to this one visit.
Potential risks and benefits
Locations (1)
- Tameside General HospitalAshton-under-Lyne, United Kingdom
Common questions
What is a diabetic foot ulcer?
It's an open sore or wound that occurs on the foot in people with diabetes, often due to high blood sugar levels and nerve damage.
What is the TASHA system?
TASHA is a new remote imaging device that uses 3D scanning to create detailed digital pictures of diabetic foot ulcers for monitoring.
Will using TASHA treat my ulcer?
No, TASHA is a monitoring tool, not a treatment. This study is testing how well it can assess ulcers, not treat them.
How long will my participation take?
Your participation is limited to one clinic visit, during which you'll have extra scans and be guided on self-scanning.
Who can join this study?
Adults (18+) with a diabetic foot ulcer being treated at the study clinic, who can sit and try self-scanning with guidance.
How to find out more
Sagar Jadeja, BDS, PhD, MFDS, AKC
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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