Varicose UlcerMOJITONCT01998932
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
An observational study of Varicose Ulcer, run by Imperial College London at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- How many people
- 28 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2013to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic venous ulceration in London and Cambridge
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF
About this study
Official title: 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.
Read more
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.
Read the 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 metabolic profiling techniques developed at Imperial College.
- Conditions
- Varicose Ulcer
- Keywords
- Venous Ulcer, Leg Ulcer, Metabolomics, Ulcer Fluid
- Medical subject headings
- Varicose Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998932
- Sponsor's protocol ID
- 13HH0574
- Other IDs
- 15384
- Acronym
- MOJITO
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2013
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Identify Biological Markers to Predict Wound Healing in Patients With Chronic Venous Ulceration of the Lower Limb
- ClinicalTrials.gov ID
- NCT01998932
- Acronym / sponsor ID
- MOJITO / 13HH0574
- Conditions
- Varicose Ulcer
- Keywords
- Venous Ulcer, Leg Ulcer, Metabolomics, Ulcer Fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Cambridge University Hospitals NHS Foundation Trust
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 metabolic profiling techniques developed at Imperial College.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic venous ulceration in London and Cambridge
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Differential Biological Response in Non Healing Ulcers Treated With a Biological Dressing.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Ulcer, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Biomarkers Predictive of Ulcer Healing. (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.