N/A
N=28
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
Varicose Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01998932 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Identification of Biomarkers Predictive of Ulcer Healing. — 9 Number of biomarkers
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Identification of Biomarkers Predictive of Ulcer Healing. |
9 | — |
| SECONDARY Differential Biological Response in Non Healing Ulcers Treated With a Biological Dressing. |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01998932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.