Safety evaluation of the DiaSole insole with diabetic foot ulcers
Research type
Research Study
Full title
Extended Phase 2 Product Evaluation Single Sample Study - To Evaluate the Safety of the DiaSole Insole for Use on Patients with Diabetic Foot Ulcers
IRAS ID
322107
Contact name
Mike Mulroy
Contact email
Sponsor organisation
Kaydiar
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
DiaSole is an insole developed to aid the treatment of diabetic foot ulcers through offloading. Offloading (reducing pressure) plays an integral role in the treatment of diabetic ulcers. DiaSole is modular in construction comprising of many 'cells', which can be individually removed to create the offloading cavity.
This study aims to evaluate the safety of DiaSole with diabetic patients who have superficial ulcers. The ulcer severity of patients included will not involve tendon, capsule or bone, or will be pre or post ulceration and have healed skin integrity (Texas wound classification 1A and 0A respectively).
The study will be conducted within Hywel Dda University Health Board (HDUHB) Podiatry services. Participants will be seen in clinic by the podiatrists emplyed within HDUHB. The patients who consent to take part will be issued a DiaSole insole as part of their usual care and under guidance of the podiatrist. The participants will be instructed to use the DiaSole as part of their ulcer offloading, for an 8-week period.
The primary outcome of this study is to assess the safety of the DiaSole insole with patients who have diabetic neuropathy and are at risk of a pressure ulcer in the feet and/or who have a superficial pressure ulcer. All adverse events and serious adverse events will be documented and used to assess the safety of DiaSole.
During the 8-week period the participants will have photographs taken of their pressure ulcer sites so that any changes to its size can be monitored. The depth of the ulcer will also be measured using a probe. The ulcer dimensions will be monitored as a secondary outcome and data will be collected during the first appointment, then again at weeks 1,2,3,4 and then week 8.
An evaluation form will also be used to capture clinician and patient feedback regarding acceptability at week 8.
REC name
Wales REC 1
REC reference
22/WA/0342
Date of REC Opinion
6 Jan 2023
REC opinion
Further Information Favourable Opinion