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

Completed

• Conditions: Varicose Ulcer

• Registration Number: NCT01998932
• Lead Sponsor: Imperial College London

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2022-06-07
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Results First Posted: 2024-11-11
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Male or female over the age of 18 years
• Chronic venous ulceration - Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85.
• Ulceration present for at least four weeks.
• Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.

Read More

Exclusion Criteria

• Acute infection in the studied lower limb within the last four weeks
• History of malignancy in the lower limb to be studied
• History of connective tissue disease
• Patients on medications that can cause immunosuppression - Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of Biomarkers Predictive of Ulcer Healing.	20 weeks	The primary outcome was biomarker identification via nuclear magnetic resonance spectroscopy and mass spectrometry. Outcome measure units - number of biomarkers predictive of ulcer healing.

Secondary Outcome Measures

Name	Time	Method
Differential Biological Response in Non Healing Ulcers Treated With a Biological Dressing.	8 weeks	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.

Trial Locations

Locations (2)

Imperial College Healthcare NHS Trust - Charing Cross Hospital; 🇬🇧 London, United Kingdom

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom