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

Sponsor

Imperial College London (Other)

Overall Status

Completed

CT.gov ID

NCT01998932

Collaborator

Imperial College Healthcare NHS Trust (Other), Cambridge University Hospitals NHS Foundation Trust (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Ulcer

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 metabonomic techniques developed at Imperial College.

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Chronic Venous Ulcer Patients with a chronic venous ulcer defined as a wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85 and a colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.

Outcome Measures

Primary Outcome Measures

Biological profile of healing venous ulcers versus non-healing venous ulcers [20 weeks]
Repeated assays at weeks 0, 1, 2, 4, 8, 12 and 20. Markers of wound healing and metabonomic assays. Ulcers will be stratified into healing and non healing and differences in the biological profiles will be determined using multivariate statistical analysis.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cambridge University Hospitals NHS Foundation Trust	Cambridge		United Kingdom
2	Imperial College Healthcare NHS Trust - Charing Cross Hospital	London		United Kingdom	W6 8RF