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
  Purpose

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
Varicose Ulcer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Human serum Human urine Human venous ulcer fluid


Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic venous ulceration in London and Cambridge

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998932

Contacts
Contact: Rahul Velineni, MRCSEd r.velineni@imperial.ac.uk

Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom
Contact: Manjit S Gohel       m.gohel@imperial.ac.uk   
Imperial College Healthcare NHS Trust - Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Contact: Alun H Davies       a.h.davies@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Alun H Davies Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01998932     History of Changes
Other Study ID Numbers: 13HH0574, 15384
Study First Received: November 25, 2013
Last Updated: December 2, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Imperial College London:
Venous Ulcer
Leg Ulcer
Metabonomics
Ulcer Fluid

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014