Diabetic Foot UlcersNCT03483467
Omnigen DFU Pilot Study
A study testing Omnigen and Dummy Packaging in people with Diabetic Foot Ulcers, run by University Hospitals of Derby and Burton NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Omnigen and Dummy Packaging
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Mar 2018to 27 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Derby and Burton, Royal Derby Hospital
Derby
University of Nottingham Teachig Hospitals, City Hospital
Nottingham
About this study
Official title: Pilot Study - Effectiveness of Omnigen in Addition to Standard Treatment in Treating Diabetic Foot Ulcers (DFU)
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).
Read the 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 Teaching Hospitals NHS Foundation Trust (DHFT) and Nottingham University Hospitals NHS Trust (NUH).
Eligible patients will be approached within diabetic foot clinics by their usual clinical carers to determine whether they are interested in participating in the study. They will be provided with written information about the study and the researcher will explain the study verbally to them and address any questions and concerns the patient may have. Patents will be given at least 24 hours to consider taking part in the trial before signing a consent form.
After informed consent has been given, baseline information will be collected. This will include demographic information, medical history and concomitant medication. eGFR and HbA1c will also be collected if not done within previous 3 months as part of standard care. The baseline wound status, assessment of ulcer infection according to Infectious Diseases Society of America (IDSA) criteria, peripheral pulses, neuropathy and ankle brachial pressure index will also be taken.
Participants will then be randomised to receive either standard of care or Omnigen graft with standard of care. Staff administering the Omnigen product will be aware of which treatment the participant is receiving however the participant and the research staff conducting the healing assessments will be blinded to their treatment allocation. Therefore the participant and the assessors will be blinded to the treatment given in order to minimize any bias in the collection of healing outcome data. For those randomized into the control arm, 'Dummy Packaging' will be used to ensure the blind is maintained.
Patients will be seen two weekly from their baseline visit until healing for up to 12 weeks and at 2 weeks post healing in those that heal. If a participant's foot ulcer heals before the final 12 weeks visit, they will attend a healing confirmation visit two weeks post the original heal date, however will not be required to attend any further fortnightly visits until the final blinded assessment visit at week 12 . If the participant's foot ulcer has not healed at 12 weeks then a blinded assessment should still be conducted at this time point.
Data is collected using the Dacima Clinical Suite Electronic Data Capture (EDC) software (Dacima Software Inc.)
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Omnigen, Dummy Packaging
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnigenOther
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.
Dummy PackagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Application of Omnigen Receives: Other: Omnigen |
| 2 | Placebo comparator | Dummy Omnigen Packaging Receives: Other: Dummy Packaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
Overall reduction in wound size (surface area, assessed by acetate tracing)
To assess the whether higher proportion of wounds reduce in size at 12 weeks in the investigational arm to the control arm - assessed by comparing acetate tracing in each arm.
Measured: 12 weeks
Time to healing (weeks) for those that heal within 12 weeks,
To assess the whether higher proportion of wounds heal at 12 weeks in the investigational arm to the control arm - assessed by proportion of confirmation of heeling visits conducted at 12 weeks within each arm.
Measured: 12 weeks
Proportion of wounds healed within 6 weeks
To assess the whether higher proportion of wounds heal at 6 weeks in the investigational arm to the control arm - assessed by proportion of confirmation of heeling visits conducted at 6 weeks within each arm.
Measured: 6 weeks
Adverse events (safety) including major and minor amputations and hospitalisation
To assess the safety of the intervention of Omnigen in comparison to standard of care. Review of SAEARs.
Measured: 12 weeks
Incidence of secondary infection
To assess the safety of the intervention of Omnigen in comparison to standard of care. Review of SAEARs.
Measured: 12 weeks
Feasibility of recruitment
To assess the feasibility of the study in regards to recruitment for a future full RCT. Recruitment rate, reasons for patients not randomising and reasons for investigators not randomising. Screening logs/protocol deviations.
Measured: 12 weeks
Pain in the area of the ulcer as assessed by patient completed VAS
To assess pain of ulcer through completion of VAS at every fortnightly visit to identify if pain reduces at a higher rate on the interventional arm than the control arm.
Measured: 12 weeks
Effectiveness of participant blind
To assess whether the blinding to arm allocation has been successful with the use of dummy packaging or whether the participants are able to identify which treatment they have received. This will be done by completion of a participant questionnaire at the end of the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start11 Mar 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- NuVision Biotherapies Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483467
- Sponsor's protocol ID
- DHRD/2017/042
- Status last verified
- Jan 2020
- First submitted
- 16 Mar 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Effectiveness of Omnigen in Addition to Standard Treatment in Treating Diabetic Foot Ulcers (DFU)
- ClinicalTrials.gov ID
- NCT03483467
- Acronym / sponsor ID
- DHRD/2017/042
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- NuVision Biotherapies Ltd
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 Teaching Hospitals NHS Foundation Trust (DHFT) and Nottingham University Hospitals NHS Trust (NUH).
Eligible patients will be approached within diabetic foot clinics by their usual clinical carers to determine whether they are interested in participating in the study. They will be provided with written information about the study and the researcher will explain the study verbally to them and address any questions and concerns the patient may have. Patents will be given at least 24 hours to consider taking part in the trial before signing a consent form.
After informed consent has been given, baseline information will be collected. This will include demographic information, medical history and concomitant medication. eGFR and HbA1c will also be collected if not done within previous 3 months as part of standard care. The baseline wound status, assessment of ulcer infection according to Infectious Diseases Society of America (IDSA) criteria, peripheral pulses, neuropathy and ankle brachial pressure index will also be taken.
Participants will then be randomised to receive either standard of care or Omnigen graft with standard of care. Staff administering the Omnigen product will be aware of which treatment the participant is receiving however the participant and the research staff conducting the healing assessments will be blinded to their treatment allocation. Therefore the participant and the assessors will be blinded to the treatment given in order to minimize any bias in the collection of healing outcome data. For those randomized into the control arm, 'Dummy Packaging' will be used to ensure the blind is maintained.
Patients will be seen two weekly from their baseline visit until healing for up to 12 weeks and at 2 weeks post healing in those that heal. If a participant's foot ulcer heals before the final 12 weeks visit, they will attend a healing confirmation visit two weeks post the original heal date, however will not be required to attend any further fortnightly visits until the final blinded assessment visit at week 12 . If the participant's foot ulcer has not healed at 12 weeks then a blinded assessment should still be conducted at this time point.
Data is collected using the Dacima Clinical Suite Electronic Data Capture (EDC) software (Dacima Software Inc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: OmnigenApplication of Omnigen |
| 2 | Placebo comparator | Other: Dummy PackagingDummy Omnigen Packaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmnigenFor 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. | Other | 1 |
| Dummy PackagingFor 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. | Other | 2 |
Primary outcome
The primary outcome is wound healing (defined as full epithelialisation without drainage maintained for 2 weeks) within 12 weeks of starting study treatment.
Time frame: 12 weeks
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.
8 secondary outcomes
Overall reduction in wound size (surface area, assessed by acetate tracing)
Time frame: 12 weeks
Time to healing (weeks) for those that heal within 12 weeks,
Time frame: 12 weeks
Proportion of wounds healed within 6 weeks
Time frame: 6 weeks
Adverse events (safety) including major and minor amputations and hospitalisation
Time frame: 12 weeks
Incidence of secondary infection
Time frame: 12 weeks
Feasibility of recruitment
Time frame: 12 weeks
Pain in the area of the ulcer as assessed by patient completed VAS
Time frame: 12 weeks
Effectiveness of participant blind
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcers
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnigen and Dummy Packaging in people with Diabetic Foot Ulcers, run by University Hospitals of Derby and Burton NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is wound healing (defined as full epithelialisation without drainage maintained for 2 weeks) within 12 weeks of starting study treatment. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.