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

NCT01998932 | Completed Results

• 2 other identifiers: 13HH057415384
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Varicose Ulcer

Keywords

Venous Ulcer; Leg Ulcer; Metabolomics; Ulcer Fluid

Outcome Measures

Primary Outcomes (1)

• Identification of Biomarkers Predictive of Ulcer Healing.

  The primary outcome was biomarker identification via nuclear magnetic resonance spectroscopy and mass spectrometry. Outcome measure units - number of biomarkers predictive of ulcer healing.

  20 weeks

Secondary Outcomes (1)

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

  8 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic venous ulceration in London and Cambridge

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Imperial College Healthcare NHS Trust - Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human serum Human urine Human venous ulcer fluid

MeSH Terms

Conditions

Varicose Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Miss Sarah Onida
• Organization: Imperial College London

s.onida@imperial.ac.uk

: +44 (0) 20 3311 7335

Study Officials

• Alun H Davies

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-09

Locations

GB (2)