Electrochemical Analysis of Wound Fluid in the Diabetic Foot
Research type
Research Study
Full title
Electrochemical Analysis of Wound Fluid in the Diabetic Foot:Fluid Sampling and Analysis
IRAS ID
177944
Contact name
Anna McLister
Contact email
Sponsor organisation
Ulster Univerisity
Duration of Study in the UK
0 years, 8 months, 14 days
Research summary
The study will investigate the characterisation of an in house manufactured pH probe in wound fluid of diabetic patients. The study will involve sampling of wound fluid by the following methods:
1. direct extraction by micropipette,
2. Periopaper® absorption and
3. fluid contained with the wound dressing removed in the course of the clinical practice.As per standard clinical treatment a swab and tissue sample will be sent to the medical microbiologist lab for further analysis.
In order to obtain the wound fluid sample, a one off procedure will be carried out on 47 diabetic patients. A signed written informed consent will be obtained from all participants on the day at which they attend the High Risk Foot clinic. The latter will be identified from attendees at Belfast City Hospital’s High Risk Foot clinics. An Advanced Podiatrist will screen the patient notes during routine clinics to identify potential participants who have a diabetic foot wound. Those thought to be suitable following consideration of the inclusion and exclusion criteria, will be approached by the researcher who will explain in detail why their help is required for the study. If the volunteer is suitable they will be asked to complete and sign a consent form at each appointment and will be provided with an information leaflet regarding the study.
Due to the time sensitive nature of the sample, the study and associated analysis will take place on the same day as consent was given. The volunteer will be made fully aware that they may withdraw their consent at any time. After completing the consent form, the volunteer will provide 10-1000 μl of wound fluid from their foot ulcer, including a sample using Periopaper®. The latter has been used in a previous study of DFU wound fluid within Belfast City Hospital (Study reference number 12/NI/0072).
REC name
Wales REC 7
REC reference
17/WA/0013
Date of REC Opinion
9 Jan 2017
REC opinion
Favourable Opinion