Venous Leg UlcerDermaRep™NCT03699072
DermaRep™ Device in the Treatment of Venous Leg Ulcers
A study testing DermaRep™ Wound Contact Device in people with Venous Leg Ulcer, run by Biovotec AS at 6 sites in United Kingdom.
Trial summary
This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- DermaRep™ Wound Contact Device
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 5 Nov 2018to 16 Sep 2020
- 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
- The patient is at least 18 years of age
- The patient is male and female not pregnant or lactating and using contraception
- The patient has a confirmed venous leg ulcer with:Confirmed actively managed reflux; No exposed tendon or bone; Ulcer surface area between 2cm2 and 80cm; ABPI>0.8
- The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
- The patient is able to understand the aims and objectives of the trial and is willing to consent
Who cannot join
- Study treatment area has exposed bone or tendon
- Poorly controlled diabetes
- Arterial insufficiency (ABPI<0.8)
- Pregnant/lactating females (tested as per institutional requirements)
- The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma granulosum)
- The patient is unable to follow the procedures set by the protocol
Show all 11Show fewer
- The patient has a history of any significant cardiac, pulmonary, renal. hepatic, neurological and/or immune dysfunction that in the opinion of the investigator may compromise patient safety or study objectives
- The patient is taking any known medications that in the opinion of the investigator may compromise patient safety or the study objectives
- The patient has any known allergies to any of the device materials to be used in the trial (egg allergy)
- The patient is a vulnerable or protected adult
- The patient is unable to provide consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Bradford Royal Infirmary
Bradford, BD9 6RJ
Countess of Chester Hospital
Chester, Ch2 1UL
Royal Free Hospital
London, NW3 2QG
Imperial College Charing Cross Hospital
London, W6 8RF
Manchester Royal Infirmary
Manchester, M13 9WL
Northern General Hospital
Sheffield, S5 7AU
About this study
Official title: A Multi-centre, Pilot, Prospective Trial of DermaRep™ Device in the Treatment of Venous Leg Ulcers
This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. All patients will then be treated with DermaRep™ wound contact dressing in addition to standard of care for a further 8 weeks. If the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. All patients will be assessed at the 16 week timepoint, the primary endpoint.
- Conditions
- Venous Leg Ulcer
- Being tested
- DermaRep™ Wound Contact Device
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaRep™ Wound Contact DeviceDevice
Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events following DermaRep™ treatment
Potential adverse events following DermaRep™ treatment will be compared to the pre-treatment phase, the 4 week run-in period. Adverse events will include active bleeding, clinical infection and device deficiencies.
Measured: 12 weeks
Secondary outcomes (10)
Evaluation of the performance of DermaRep™ in rate of wound healing.
Qualitative evaluation of wound healing progression will be assessed visually by the treating clinician
Measured: 12 weeks
Assessment of Wound Pain
Wound pain will be assessed using a VAS score.
Measured: 12 weeks
DermaRep™ Dressing Application
Pain on dressing changes will be assessed using a VAS score
Measured: 12 weeks
Wound coverage
Wound coverage will be calculated as a percentage from baseline to the end of the study using wound grids for area measurement
Measured: 12 weeks
Comparison of healing between the run-in period and the treatment period
The rate of progression in wound healing during the treatment phase relative to the pre-treatment run-in phase will be assessed by surface area measurement using wound grids.
Measured: 12 weeks
Wounds healed at 12 weeks
The number of wounds healed at the final assessment will be assessed.
Measured: 12 weeks
Reduction in wound area/volume
The % reduction in area and volume of the wound will be assessed by measurement with wound grids and a ruler.
Measured: 12 weeks
Time to healing
Time to healing for healed wounds will be assessed in weeks.
Measured: 12 weeks
Exudate levels
Exudate levels will be assessed qualitatively (low, medium, high) by the treating clinician.
Measured: 12 weeks
Condition of the surrounding skin
The condition of the surrounding skin will be described qualitatively by the treating clinician
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 posted9 Oct 2018
- Study start5 Nov 2018
- Primary completion1 Apr 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biovotec AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin G Mercer, MD, Principal investigator, Bradford Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699072
- Sponsor's protocol ID
- BV-CP-01
- Acronym
- DermaRep™
- Status last verified
- Dec 2020
- First submitted
- 3 Oct 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Pilot, Prospective Trial of DermaRep™ Device in the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03699072
- Acronym / sponsor ID
- DermaRep™ / BV-CP-01
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Biovotec ASIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 9 Oct 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.
This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. All patients will then be treated with DermaRep™ wound contact dressing in addition to standard of care for a further 8 weeks. If the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. All patients will be assessed at the 16 week timepoint, the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is at least 18 years of age
- The patient is male and female not pregnant or lactating and using contraception
- The patient has a confirmed venous leg ulcer with:Confirmed actively managed reflux; No exposed tendon or bone; Ulcer surface area between 2cm2 and 80cm; ABPI>0.8
- The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
- The patient is able to understand the aims and objectives of the trial and is willing to consent
Key exclusion criteria (11 listed)
- Study treatment area has exposed bone or tendon
- Poorly controlled diabetes
- Arterial insufficiency (ABPI<0.8)
- Pregnant/lactating females (tested as per institutional requirements)
- The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma granulosum)
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 |
|---|---|---|
| DermaRep™ Wound Contact DeviceTreatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings | Device | – |
Primary outcome
Assessment of adverse events following DermaRep™ treatment
Time frame: 12 weeks
Potential adverse events following DermaRep™ treatment will be compared to the pre-treatment phase, the 4 week run-in period. Adverse events will include active bleeding, clinical infection and device deficiencies.
10 secondary outcomes
Evaluation of the performance of DermaRep™ in rate of wound healing.
Time frame: 12 weeks
Assessment of Wound Pain
Time frame: 12 weeks
DermaRep™ Dressing Application
Time frame: 12 weeks
Wound coverage
Time frame: 12 weeks
Comparison of healing between the run-in period and the treatment period
Time frame: 12 weeks
Wounds healed at 12 weeks
Time frame: 12 weeks
Reduction in wound area/volume
Time frame: 12 weeks
Time to healing
Time frame: 12 weeks
Exudate levels
Time frame: 12 weeks
Condition of the surrounding skin
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 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Kevin G Mercer, MD principal investigator
Bradford Teaching Hospitals NHS Foundation Trust
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermaRep™ Wound Contact Device in people with Venous Leg Ulcer, run by Biovotec AS at 6 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 5 inclusion and 11 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
Assessment of adverse events following DermaRep™ 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 16 Dec 2020.