Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.
Diabetes Mellitus Foot Ulcer
About this trial
This is an interventional treatment trial for Diabetes Mellitus Foot Ulcer
Eligibility Criteria
Inclusion Criteria: Age 18 years and above Capacity to consent UK Shoe size 3-11 Diagnosis of Diabetes Sensory 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 insole Clinical signs of or confirmed active infection (soft tissue or osteomyelitis) History of or active Charcot foot or severe foot deformity Amputation Critical limb ischemia or diagnosed moderate to severe peripheral arterial disease Inappropriate footwear (does not accommodate the DiaSole insole) Visual impairment (cannot see feet and footwear properly) Sensory neuropathy of the upper limbs/hands History of drug and alcohol abuse• Have known contraindications to the materials used in the product insoles. Allergies to cotton or silicone Have an infectious disease, which may pose as a potential risk to the researchers and clinicians Are enrolled into another study Unable to attend regular hospital visits - e.g. housebound Are unwilling to take part in the study Are currently enrolled in any other research Individuals who do not adequately understand verbal explanations of written information in English, unless there is access to a qualified translator Are not suitable for the evaluation, according to the podiatrist's or nurse's clinical judgement
Sites / Locations
Arms of the Study
Arm 1
Experimental
Main study
Study to investigate the safety and clinical efficacy of the DiaSole insole.