Varicose Ulcer
Conditions
Keywords
Venous Ulcer, Leg Ulcer, Metabolomics, Ulcer Fluid
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.
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.
Interventions
None listed
Sponsors
Imperial College Healthcare NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of Biomarkers Predictive of Ulcer Healing. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differential Biological Response in Non Healing Ulcers Treated With a Biological Dressing. | 8 weeks | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Chronic Venous Ulcer | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 22 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 71 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 28 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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.
Time frame: 20 weeks
Population: Data from all participants was analysed, subgrouped by participants who healed and those who did not heal
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chronic Venous Ulcer | Identification of Biomarkers Predictive of Ulcer Healing. | 9 Number of biomarkers |
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.
Time frame: 8 weeks
Population: This part of the study was not performed