Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.

Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions. It may be possible to use the DiaSole for other causes of neuropathic foot ulcerations (such as rheumatoid arthritis), but the safety of the insole needs assessing first. There is already evidence to support the use of offloading insoles in the healing and prevention of pressure ulcers, DiaSole may be an improved insole for this purpose.

Inclusion Criteria:Age 18 years and aboveCapacity to consentUK Shoe size 3-11Diagnosis of DiabetesSensory neuropathy (lack of perception of 10g monofilament in one or more sites of the feet)Active foot ulceration (plantar aspect), grade 1a using the University of Texas wound grading system (grade 1a)Appropriate footwear (which has room to safely accommodate the DiaSole insole)At risk of ulceration or re-ulceration (Grade 0A)Exclusion Criteria:Patients who are non-concordant and do not have appropriate footwear that could house the DiaSole insoleClinical signs of or confirmed active infection (soft tissue or osteomyelitis)History of or active Charcot foot or severe foot deformityAmputationCritical limb ischemia or diagnosed moderate to severe peripheral arterial diseaseInappropriate footwear (does not accommodate the DiaSole insole)Visual impairment (cannot see feet and footwear properly)Sensory neuropathy of the upper limbs/handsHistory of drug and alcohol abuse• Have known contraindications to the materials used in the product insoles. Allergies to cotton or siliconeHave an infectious disease, which may pose as a potential risk to the researchers and cliniciansAre enrolled into another studyUnable to attend regular hospital visits - e.g. houseboundAre unwilling to take part in the studyAre currently enrolled in any other researchIndividuals who do not adequately understand verbal explanations of written information in English, unless there is access to a qualified translatorAre not suitable for the evaluation, according to the podiatrist's or nurse's clinical judgement