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| ID | Type | Description | Link |
|---|---|---|---|
| 15384 | Other Identifier | UK National Institute for Health Research (NIHR) Clinical Research Network Portfolio |
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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
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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 metabolic profiling techniques developed at Imperial College.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic venous ulceration in London and Cambridge
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| Name | Affiliation | Role |
|---|---|---|
| Alun H Davies | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom | ||||
| Imperial College Healthcare NHS Trust - Charing Cross Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data from all participants was analysed, subgrouped by participants who healed and those who did not heal | Posted | Number | Number of biomarkers | 20 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Sarah Onida | Imperial College London | : +44 (0) 20 3311 7335 | s.onida@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2013 | Sep 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
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Human serum Human urine Human venous ulcer fluid
| London |
| W6 8RF |
| United Kingdom |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | This part of the study was not performed | Posted | 8 weeks |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
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| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |