FeetSee thermal images for people with diabetes who have healed plantar ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational study enrolling adults with type 1 or type 2 diabetes and a recently healed plantar diabetic foot ulcer, who also have neuropathy. Participants use a FeetSee thermal camera attached to their own device to take daily plantar foot images at home, with data securely uploaded for analysis. The study aims to identify temperature patterns that may precede ulceration and to evaluate the feasibility and adherence of home-based thermal imaging in this population. Recruitment occurs at hospital sites in the UK and Lithuania, with follow-up through device support and periodic check-ins. Key exclusions include active ulcers, Charcot disease, severe vascular disease, or other conditions that would hinder safe device use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males/females aged over 18 years.
* Type 1 or type 2 diabetes.
* History of plantar diabetic foot ulcer(s).
* Foot ulcer healed for at least 6 weeks before entry into study, as determined by a specialist healthcare provider.
* Presence of diabetic peripheral neuropathy defined by either of the following:

  * Inability to detect the monofilament (10g) applied at two foot sites, including the apex of the Hallux (ADA guidelines 2008 Diabetes Care 31(1)).
  * A Vibration Perception Threshold (VPT) \>20V, and/or by inability to detect application of the monofilament at the apex of the Hallux.
* Presence of at least one palpable foot pulse.

Exclusion Criteria:

* Active foot ulceration.
* Active Charcot neuro-osteoarthropathy.
* Severe vascular disease (complete absence of any foot pulses).
* Lower limb/foot amputation greater than metatarsophalangeal disarticulation.
* Active malignancy, immunosuppressive disease.
* Physical or mental condition(s) that limit the ability to follow instructions for the study, based on clinical judgment by the physician, such as inability to use the device without assistance.
* Current participation in another clinical investigation of a medical device that is contraindicated for either study procedure/outcome.

Where it's running

• Vilnius University Hospital Santaros Klinikos
  Vilnius, Lithuania Recruiting
• Manchester University NHS Foundation Trust (MFT)
  Manchester, United Kingdom Recruiting
• Blackpool Teaching Hospitals NHS Trust
  Blackpool, United Kingdom Not yet recruiting
• Lancashire Teaching Hospitals NHS Foundation Trust
  Lancaster, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: Neil Reeves, Prof, Phd — Manchester University NHS Foundation Trust (MFT)
• Study coordinator: Helena Grinberg Rashi, Phd
• Email: helena@diabetis.lt
• Phone: +31615636666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.