Status:
COMPLETED
Omnigen DFU Pilot Study
Lead Sponsor:
University Hospitals of Derby and Burton NHS Foundation Trust
Collaborating Sponsors:
NuVision Biotherapies Ltd
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Omnigen Pilot study aims to provide an evidence base for Omnigen as a treatment for Diabetic Foot Ulcers (DFU). It aims to achieve this by tailoring a regenerative therapy used for ocular surface ...
Detailed Description
This pilot study is designed as a multi-centre prospective, patient and observer blind, randomised controlled trial, recruiting patients from two clinical centres across the East Midlands; Derby Teach...
Eligibility Criteria
Inclusion
- Patients with diabetes (according to WHO criteria) aged 18 years or over
- At least one full thickness ulcer below the malleolus of either foot, present for 4 weeks or more.
- At least one palpable pulse on the foot of the index limb or an ABPI \>0.9
- Minimum ulcer diameter of 5 mm
- Maximum ulcer diameter of 20 mm.
- Able to attend clinic on a fortnightly basis
Exclusion
- eGFR \<20
- HbA1c \>108
- Planned revascularisation during the course of the study or within the 4 weeks preceding the start of the study
- An ulcer of aetiology other than diabetes
- Depth of ulcer to bone, suspected or confirmed osteomyelitis
- Severe infection of the index ulcer
- Active Charcot of the foot of the index ulcer
- The need for negative pressure wound therapy
- On treatment with systemic steroids at a dose \> equivalent of 5mg prednisolone for more than 5 days and/or systemic cytotoxic agents
- Unwilling or unable to attend all trial visits.
- Unwilling or unable to give written informed consent.
- Lacks the mental capacity to give consent
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, may influence the result of the trial or the participant's ability to participate in the trial
- Participants who have participated in another research trial involving a wound healing product within the past 12 weeks
Key Trial Info
Start Date :
March 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03483467
Start Date
March 11 2018
End Date
June 27 2019
Last Update
January 9 2020
Active Locations (2)
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1
University Hospitals Derby and Burton, Royal Derby Hospital
Derby, United Kingdom
2
University of Nottingham Teachig Hospitals, City Hospital
Nottingham, United Kingdom