OASIS Extracellular Matrix Long-term Data Plan
Research type
Research Study
Full title
Treatment of Wounds Using Oasis Extracellular Matrix in the Community Setting: Long-term Data Collection
IRAS ID
298155
Contact name
Jason Hodde
Contact email
Sponsor organisation
Cook Biotech Incorporated
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
The objective of this Post-Market Clinical Follow-up (PMCF) Data Collection is to determine when each of the previously enrolled patients enrolled in Study IRAS ID:246466 and treated with OASIS Extracellular Matrix were confirmed to demonstrate complete healing of their chronic leg ulcer. We plan to examine NHS medical records of the patients that were treated with OASIS to determine the number of nursing visits performed and the date of wound healing observed after the patients' participation in the study was completed.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0129
Date of REC Opinion
17 Jun 2021
REC opinion
Further Information Favourable Opinion