‘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

  F.Iwuagwu@nhs.net

• 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

  "Research 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.

  "Summary of results"
  Background Chronic leg ulcers are a problem that affects hundreds of thousands of people in the UK. It is a cause of significant social and economic burden to both the sufferers and the NHS.

  Question:
  We wondered if certain germs called fungi are deep within the tissues delaying their healing or making them not to heal. These germs are often not the focus as there tends to be more focus on germs like bacteria and viruses. Most of the routine specimens sent from patients with chronic leg ulcers are swabs which identify germs which may just be contaminants from the environment and not the actual cause of the disease. And even when the deep samples are sent (like in a biopsy), traditional laboratory methods frequently fail to identify these germs. But advanced techniques like molecular diagnostics can help identify these germs.

  Aim
  Our aim was to identify germs that may delay or prevent healing, thereby informing targeted therapeutic or treatment strategies.
  We hoped that if we find these organisms in a small number of patients, we can then carry out the study on many more patients. And if we find the same in a larger number of patients, it means that plans can be made to treat the offending germs.

  Method
  In this pilot study, we used polymerase chain reaction commonly referred to as PCR to detect fungal pathogens in tissue samples from ten patients with chronic leg ulcers. It is an advanced technique that can identify the DNA of fungal germs in the deep parts of the specimen.

  Results
  We successfully extracted DNA from all ten patients, with two samples taken from the centre and periphery of each ulcer. We identified two fungal germs in most of the specimens. The identification of fungal DNA is significant, given the well-known fact that they can cause disease in different parts of the body including skin infections. These findings warrant further investigation to elucidate their role in ulcer persistence.

  Future (way forward)
  We therefor need to do the study on a larger sample of patients. We plan to submit a protocol for ethical approval to study about thirty patients with chronic leg ulcers. A confirmation of our finding will enable us to develop antifungal treatment strategy for patient with chronic leg ulcers.
  Secondly, it is hoped that in the future, these advanced detection techniques would become part of routine care in hospitals as it will enable earlier, better detection of germs within the tissues, and therefore earlier specific treatment and improved quality of care for people affected by chronic leg ulcers

• REC name

  Wales REC 7

• REC reference

  20/WA/0255

• Date of REC Opinion

  15 Sep 2020

• REC opinion

  Favourable Opinion