The Omnigen Diabetic Foot Ulcer Pilot Study
Research type
Research Study
Full title
Pilot study - Effectiveness of Omnigen in addition to standard treatment in treating Diabetic Foot Ulcers (DFU)
IRAS ID
235573
Contact name
Teresa Grieve
Contact email
Sponsor organisation
Derby Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The Omnigen Pilot study aims to provide an evidence base for Omnigen, freeze dried amniotic tissue, as a treatment for Diabetic Foot Ulcers (DFU).
Omnigen is a dry, human amniotic membrane-derived therapy, which has demonstrated good outcomes in treating non-healing chronic ulcers, and disease of the surface of the eye. This pilot study aims to evaluate the effects of Omnigen as an addition to standard care in the treatment of different non-healing ulcers, those related to the diabetic foot.
This pilot study is designed as a prospective, patient and observer blind, randomised controlled trial, recruiting patients from two clinical centres in the East Midlands; Derby Teaching Hospitals NHS Foundation Trust (DHFT) and Nottingham University Hospitals NHS Trust (NUH).
REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0025
Date of REC Opinion
21 Feb 2018
REC opinion
Favourable Opinion