Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer. However, the pathophysiological abnormalities are not entirely clear in how raised venous pressure translates into the changes seen in the skin culminating in an open ulcer. The standard treatment of this condition in the United Kingdom is to undertaken compression bandaging of the lower limb. In order to further their knowledge of venous ulceration, the investigators seek to determine the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing the groups into healing and non-healing wounds, the investigators may be able to demonstrate a difference in the biological profile. This work may provide insights into predicting who will respond to treatment and targets for treatment in the future.
Forty patients with chronic venous ulceration of the lower limb who meet the inclusion criteria will be entered into the study and assessed over a twenty week period with assessments at week 0, 1, 2, 4, 8, 12 and 20. Urine, serum and ulcer fluid will be sampled. If the ulcer has not healed, further assessments using an approved biological dressing will be undertaken at weeks 20, 21, 22, 23, 25 and 28 with further sampling of ulcer fluid, urine and serum. Samples will undergo metabolic profiling using established metabolic profiling techniques developed at Imperial College.
Study Type
OBSERVATIONAL
Enrollment
28
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, United Kingdom
Identification of Biomarkers Predictive of Ulcer Healing.
The primary outcome was biomarker identification via nuclear magnetic resonance spectroscopy and mass spectrometry. Outcome measure units - number of biomarkers predictive of ulcer healing.
Time frame: 20 weeks
Differential Biological Response in Non Healing Ulcers Treated With a Biological Dressing.
Non healing ulcers at twenty weeks will be treated in addition to standard dressing with a biological augmented dressing approved for use in the UK. This will determine if an alternative biological profile can be obtained representing a 'healing' response.
Time frame: 8 weeks
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