‘Subclinical’ infection in tissues in Chronic leg ulcers -PILOT study
Research type
Research Study
Full title
Identification of ‘subclinical’ infection in the deep tissues in Chronic Leg Ulcers – a prospective PILOT study
IRAS ID
279606
Contact name
Fortune Iwuagwu
Contact email
Sponsor organisation
Mid South Essex NHS FT
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
SUMMARY This is a pilot study based on the hypothesis or thinking that there is an unidentified infection of chronic ulcers (skin defects or wounds) by germs called fungi within the tissues of a chronic ulcer and this may be responsible for the delayed healing or non-healing of the ulcers. For this proposal, the word 'ulcer' is the same as the word 'wound' and the same as the phrase 'skin defect'. These are the terms that will be used to describe the word 'ulcer.
The study will be on tissues taken from 10 (ten) patients suffering from chronic leg ulcers (wounds) to see if the tissues harbour certain germs called fungi that are potentially causing chronic infection. Chronic leg ulcers are skin defects or wounds on the legs below the knees that are persisting for more than six weeks and show no tendency to heal after three months or more of appropriate treatment or are still not fully healed at 12 months.
Tests on the tissue will be carried out using a specialized test called polymerase chain reaction (PCR). We are also hoping to see whether the presence of these germs means there is less of other common germs, especially a type of bacteria called staphylococcus.
If our hypothesis or thinking is correct, it is hoped to demonstrate the presence of some species of these germs (fungi) in the tissues taken for use in our pilot study.
REC name
Wales REC 7
REC reference
20/WA/0255
Date of REC Opinion
15 Sep 2020
REC opinion
Favourable Opinion