Venous Leg Ulcers Study
Study Background
A Venous Leg Ulcer (VLU) occurs when the veins in the legs do not pump blood back to the heart properly, causing blood to pool in the veins and build up pressure. The increased pressure and excess fluid can lead to an open sore, which can have a significant impact on the quality of life of those affected.
There is an unmet need for safe, effective treatment for people living with VLUs. VLUs struggle to heal due to problems with blood flow, which causes swelling and can impact healing.
Current treatments involve wound management and long-term compression management, however approximately 30% of VLUs still fail to heal, and wounds that heal may re-open after months or years.
This study is investigating a new potential treatment for VLUs, a clear gel containing an experimental drug that is applied directly to the VLU; compared to a control placebo gel treatment.
Study Details
The study would require you to come in for 7 visits over a 2-month period. The Screening visit will last about 8 hours, the Treatment visit will last about 4 hours and the remaining 5 visits will take about 1 hour to complete.
During your first visit, the doctor will confirm the eligibility criteria for the study, take routine blood tests, perform a baseline ECG, and conduct a physical examination and wound assessment. On your second visit you will be randomised into a study treatment group, and administered the study treatment (either the gel containing the experimental drug, or the control placebo gel which does not contain any active/experimental drug).
Eligibility Criteria
- Male or female ≥ 18
- Diagnosed with a VLU
- VLU must be present for more than 1 month