Clinical trial NCT01998932: Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
Official title: Clinical Study to Identify Biological Markers to Predict Wound Healing in Patients With Chronic Venous Ulceration of the Lower Limb
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Ulcer
Keywords: Venous Ulcer
Leg Ulcer
Metabolomics
Ulcer Fluid
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2013-12-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic venous ulceration in London and Cambridge

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Identification of Biomarkers Predictive of Ulcer Healing.
timeFrame: 20 weeks
Secondary outcomes:
measure: Differential Biological Response in Non Healing Ulcers Treated With a Biological Dressing.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Alun H Davies
role: PRINCIPAL_INVESTIGATOR
References: