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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Imperial College London
Sponsor:
Collaborators:
Imperial College Healthcare NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01998932
First received: November 25, 2013
Last updated: December 2, 2013
Last verified: June 2013

November 25, 2013
December 2, 2013
November 2013
February 2015   (final data collection date for primary outcome measure)
Biological profile of healing venous ulcers versus non-healing venous ulcers [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01998932 on ClinicalTrials.gov Archive Site
Differential biological response in non healing ulcers treated with a biological dressing. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
Clinical Study to Identify Biological Markers to Predict Wound Healing in Patients With 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Human serum Human urine Human venous ulcer fluid

Non-Probability Sample

Patients with chronic venous ulceration in London and Cambridge

Varicose Ulcer
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
February 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Rahul Velineni, MRCSEd r.velineni@imperial.ac.uk
United Kingdom
 
NCT01998932
13HH0574, 15384
No
Imperial College London
Imperial College London
  • Imperial College Healthcare NHS Trust
  • Cambridge University Hospitals NHS Foundation Trust
Principal Investigator: Alun H Davies Imperial College London
Imperial College London
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP