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

Varicose Ulcer Clinical Trial

— MOJITO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998932
• Other study ID #: 13HH0574
• Secondary ID: 15384
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: June 29, 2015
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Varicose Ulcer

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Imperial College Healthcare NHS Trust - Charing Cross Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Cambridge University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological profile of healing venous ulcers versus non-healing venous ulcers	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.	20 weeks	No
Secondary	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.	8 weeks	No