NCT01998932

Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb

Clinical Study to Identify Biological Markers to Predict Wound Healing in Patients With Chronic Venous Ulceration of the Lower Limb

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Varicose Ulcer

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-12-03
• Last updated: 2024-11-12
• Results posted: 2024-11-12

Locations

2 sites across 1 country: United Kingdom