Omnigen DFU Pilot Study

NCT03483467 | Completed

• 1 other identifier: DHRD/2017/042
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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 repair to provide proactive non-surgical wound management of Diabetic Foot Ulcers (DFU).

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• The primary outcome is wound healing (defined as full epithelialisation without drainage maintained for 2 weeks) within 12 weeks of starting study treatment.

  To assess the whether higher proportion of wounds heal at 12 weeks in the investigational arm to the control arm - assessed by confirmation of healing at 12 week visit.

  12 weeks

Secondary Outcomes (8)

• Overall reduction in wound size (surface area, assessed by acetate tracing)

  12 weeks

• Time to healing (weeks) for those that heal within 12 weeks,

  12 weeks

• Proportion of wounds healed within 6 weeks

  6 weeks

• Adverse events (safety) including major and minor amputations and hospitalisation

  12 weeks

• Incidence of secondary infection

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Application of Omnigen

Other: Omnigen

2

PLACEBO COMPARATOR

Dummy Omnigen Packaging

Other: Dummy Packaging

Interventions

Omnigen OTHER

For those randomised onto the investigational arm, a dual layer of the Omnigen product will be applied at baseline and at every fortnightly trial visit until healing or the end of the 12 week period whichever occurs first, according to the standard study procedure.

1

Dummy Packaging OTHER

For those randomised into the control arm, dummy packaging will be opened at the time of application of standard of care, to ensure the same experience is received to those on the experiential arm.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• NuVision Biotherapies Ltd: collaborator

Study Sites (2)

University Hospitals Derby and Burton, Royal Derby Hospital

Derby, United Kingdom

Location

University of Nottingham Teachig Hospitals, City Hospital

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 30, 2018
• Study Start: March 11, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)