BASICHR0009
Research type
Research Study
Full title
Longitudinal study of human skin wounds BASICHR0009
IRAS ID
235381
Contact name
Orla Prendiville
Contact email
Sponsor organisation
Novartis Pharma AG
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study is Phase 2 of a 2 part project the aim of which is to prepare the path for a new generation of therapeutic approaches that provide considerable improvements in outcomes for patients with chronic wounds.
Phase 1, which was completed in 2016, assessed the technical feasibility of sampling wound fluid, serum and biopsies, in a clinical setting and performing laboratory assessments on these samples. No clinical information was collected and the only success criteria was the generation of interpretable profiling data from the samples. Overall, the quality of the obtained samples was acceptable and all sample types collected could be used to generate profiling data. The results have been used to guide the choice of samples to be taken in Phase 2.
We are now ready to start Phase 2, which is a longitudinal, 12 week, non-drug study, with the inclusion of low-interventional procedures to assess patients with venous disease and/or diabetes who have chronic ulcers. The total recruitment goal is 100 adult patients by study sites in the United Kingdom and United States. The purpose of Phase 2 is to explore the relationship between both the clinical and molecular aspects in patients with chronic wounds.
REC name
Wales REC 2
REC reference
17/WA/0419
Date of REC Opinion
19 Dec 2017
REC opinion
Favourable Opinion