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

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.

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Key information

Conditions

Varicose Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Identification of Biomarkers Predictive of Ulcer Healing.

Time frame: 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 outcomes

Differential Biological Response in Non Healing Ulcers Treated With a Biological Dressing.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

Cambridge University Hospitals NHS Foundation Trust
Imperial College Healthcare NHS Trust

Registry information

Official study title

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

Acronym: MOJITO

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Dec 3, 2013
Registry last updated: Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed