Pressure-Sensing Insoles in the Neuropathic Ulcer Treatment Pathway (PINUP)
Diabetes, Diabetes Complications, Neuropathy
About this trial
This is an interventional treatment trial for Diabetes focused on measuring wearable technology, Orpyx, SurroSense Rx, smart insole, TCC, total contact cast, insole, removable cast walker, RCW
Eligibility Criteria
Inclusion Criteria:
- Diabetes (according to AAFP diagnostic criteria )
- Presence of neuropathy with Loss of Protective Sensation (LOPS), as defined by any loss of sensation as per the assessments included in the Modified Neuropathy Disability Score (MNDS)
Active plantar diabetic foot ulcer (Grade 1A, according to the University of Texas Wound Classification System , )
- A minimum size ulcer ≥0.5cm2 and ≤ 12 cm2 post debridement at time of randomization
- If the subject has more than one ulcer, they should be identified and at least 2 cm apart
- Age >18
- At least one palpable foot pulse
- Ability to understand all of the study requirements
- Life expectancy greater than the duration of the study
- Subject or responsible caregiver is willing and able to maintain the required offloading (as applicable for the location of the ulcer) and applicable dressing changes
- Doppler Ultrasound positive for at least one pedal pulse in each foot
Exclusion Criteria:
- Weight > 400 lb (182 kg)
- Uncorrected visual impairment
- Active Infection
- Non-plantar ulcers on the ankle, posterior heel, or other location
- More than one active plantar ulcer
- Presence of severe ischemia (any of: absence of foot pulses, Ankle Brachial Index 0.6 > [ABI] > 1.2, capillary refill time > 5 seconds; see Appendix 3)
- Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study
- Current smokers
Active abuse of alcohol
o Subject has a history of any of the following intercurrent illnesses or conditions that would compromise the safety of the subject or the normal healing process:
- End-stage renal disease
- Immunosuppression
- Severe malnutrition
- Liver disease
- Aplastic anemia
- Scleroderma
- Acquired immune deficiency disease (AIDS) or HIV positive
- Connective tissue disorder
- Exacerbation of sickle cell anemia
- Active Charcot foot
- Excessive lymphedema
- Osteomyelitis and gangrene
Subjects with ulcers secondary to a disease other than diabetes (e.g. vasculitis, neoplasms or haematological disorders)
o At the end of the run-in period and prior to randomization, the subject be excluded if the following conditions are not met:
- Subject does not continue to meet the entrance criteria (inclusion and exclusion)
- The size of the study ulcer, following debridement, has decreased by more than 30% from the baseline assessment measured at screening.
- Abnormal toe and/or ankle range of motion
Sites / Locations
- Zivot Limb Preservation Centre- Peter Lougheed Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Sham Comparator
Sham Comparator
Active SurroSense Rx System + RCW
Inactive SurroSense Rx System + RCW
Inactive SurroSense Rx System + iTCC
Patients randomized to the experimental group will be fitted with an active (alerting) version of the SurroSense R® smart insole System. This device will be placed in the RCW, underneath the liner. The device tab will be fed up the instep, through a hole in the liner, and affixed to the dorsum of the RCW by way of a tie.
Patients randomized to this group will be fitted with an inactive (non-alerting) version of the device in an identical fashion.
Patients in this group will be fitted with an inactive (non-alerting) version of the device in an identical fashion. The RCW will be further secured using a device specific tie such that it acts as an iTCC.