Venous UlcerDAVENCT04021316
Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration
A study testing dCELL® Human Dermis (decellularised dermal skin allograft - DCD) and Compression bandaging therapy in people with Venous Ulcer and Allograft, run by Imperial College London at 17 sites in United Kingdom.
Trial summary
Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer, Allograft
- What is being tested?
- dCELL® Human Dermis (decellularised dermal skin allograft - DCD) and Compression bandaging therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 1 Oct 2019to 10 Apr 2023
- 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
- ≥18 years or older (no upper age limit)
- The ability to consent to participation
- A diagnosis of venous leg ulceration* (defined as 'colour duplex confirmation of superficial and or deep venous reflux with any break in the skin that has either: a) been present for more than 2 weeks, or b) occurred in a person with a history of venous leg ulceration)
- Documented venous incompetence on duplex ultrasound
- Index ulcer wound duration of greater than 3 months
- Index ulcer wound size ≥ 2 cm2.
- ABPI ≥ 0.8
- in light of the Covd-19 pandemic, the use of handheld continuous wave Dopplers will be allowed to diagnose venous disease to allow participants to be recruited from clinic without the need for an imaging appointment
Who cannot join
- A diagnosis of sickle cell
- Unable to receive one or more of the randomised treatment strategies for any reason at the discretion of the attending clinical team (e.g. known allergies to dCELL dermis preparation components)
- A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
- Treatment with biomedical/topical growth factors within previous 30 days
- Previous history of an inability to tolerate compression therapy
- Foot ulcer (i.e. below the ankle)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
North Bristol NHS Trust
Bristol
Cardiff and Vale University Health Board
Cardiff
North Cumbria University Hospitals NHS Trust
Carlisle
Gloucestershire Hospitals NHS Foundation Trust
Gloucester
AT Medics
London
Guy's and St Thomas' NHS Foundation Trust
London
Imperial College Healthcare NHS Trust
London
London North West University Healthcare
London
St Charles Centre for Health and Welbeing, Central London Community Healthcare NHS Trust
London
Aneurin Bevan University Health Board
Newport
Northampton General Hospital NHS Trust
Northampton
Livewell
Plymouth
University Hospitals Plymouth NHS Trust
Plymouth
Swansea Bay University Health Board
Swansea
Taunton and Somerset NHS Foundation Trust
Taunton
Mid Yorkshire Hospitals NHS Trust
Wakefield
Worcestershire Acute Hospitals NHS Trust
Worcester
About this study
Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone
Read the detailed description
Chronic venous ulceration are open wounds on the lower limbs which have been present for at least three months and are caused by a poorly functioning venous system. The affect about 1% of the general population and about 4% of those over 65. The wounds cause pain, reduced movement, and can smell - greatly affecting the quality of life of leg ulcer patients. The standard care for these patients is compression bandaging, which requires changing several times a week by community or district nurses; this drives the high cost of leg ulcer care, which can amount to £2.5 billion per annum.
Skin grafting can be used alongside compression bandaging and can help the ulcers heal faster than compression alone. Grafts can be taken from the patient's own skin, from a donor or from tissue engineered skin. An autograft (using own skin) can cause scarring and the need for a formal surgical procedure in theatre so are not suitable for all ulcer patients. Allografts (donor skin) and xenografts (animal skin) have been used successfully, but present similar drawbacks to autografts, plus the potential for the body to reject the graft and disease transmission. Tissue engineered skin has several advantages as it has been processed to remove the cells, and therefore is won't be rejected via the immune response. Human decellularised dermis (DCD) is generated from donated skin from deceased people and processed to remove the cells. It can be glued or sewn onto the skin under local anesthetic, in an out patient setting. DCD has mainly been studied in patients with diabetic foot ulceration and has shown improved healing rates and quality of life.
This study will investigate the use of DCD in addition to compression therapy versus compression therapy alone in patients with chronic venous leg ulceration.
- Conditions
- Venous Ulcer, Allograft
- Being tested
- dCELL® Human Dermis (decellularised dermal skin allograft - DCD), Compression bandaging therapy
- Keywords
- Compression therapy, Ulcer
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCELL® Human Dermis (decellularised dermal skin allograft - DCD)Other
DCD is produced from split thickness skin grafts (which comprise the epidermis and upper part of the dermis), and is retrieved from deceased tissue donors. All epidermal and cellular components from the dermis are removed in a patented sequential decellularisation process. As a decellularised graft, dCELL® Human Dermis fully integrates into the wound bed after application, replacing lost dermal tissue. It provides a scaffold into which the recipient's cells can grow, becoming vascularised and supporting the generation of a new epidermis, ultimately regenerating into normal skin.
Compression bandaging therapyOther
Compression therapy will be according to local practice and may include multilayer elastic compression bandaging or stockings delivering 20 to 40mm/Hg pressure.
| Study group | Role | What they receive |
|---|---|---|
| Standard care arm | Active comparator | Compression bandaging therapy as per standard care Receives: Other: Compression bandaging therapy |
| DCD Arm | Experimental | DCD graft plus compression bandaging therapy as per standard care Receives: Other: dCELL® Human Dermis (decellularised dermal skin allograft - DCD); Other: Compression bandaging therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with a healed index ulcer at 12 weeks after randomisation.
Measured: 12 weeks
Secondary outcomes (8)
Time to index ulcer healing from randomisation
Measured: 12 months
The percentage change in index ulcer area in cm2 at 12 weeks from randomisation
Measured: 12 weeks
The proportion of participants with a healed index ulcer at 12 months from randomisation
Measured: 12 months
The proportion of participants whose index ulcer healed for whom an ulcer recurred at the index site within 12 months from randomisation
Measured: 12 months
Generic quality of life using the EuroQol-5D (EQ-5D) questionnaire
A health index on a score of 0 to 1 and the participants' self-rated health on a vertical score of zero to 100. Higher scores indicate better quality of life
Measured: 12 weeks, 6 months and 12 months from randomisation
Disease specific quality of life using the Charing Cross Venous Ulcer Questionnaire (CCVUQ)
Scale 0 to 100, with lower scores indicating better quality of life
Measured: 12 weeks, 6 months and 12 months from randomisation
The cost for each patient, calculated from the healthcare resources used
Measured: 12 months
Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis
An intervention may be considered cost-effective when its ICER is less than the threshold set by health policy decision-makers. In the UK, the cost-effectiveness threshold is currently in the range £20 000-30 000 per QALY
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Oct 2019
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Why it stopped: DMC noted that the primary end point of healed index ulcer at 12 weeks was reached only in 11.5%, whereas a higher figure of 42.5% had been used for the original power calculation, suggesting the trial is significantly underpowered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Model description
- Participants will undergo 1:1 web based randomisation to either standard care or the intervention via an automated system. A minimization algorithm using centre, index ulcer size and duration will be used, including a random component to lessen predictability. A separate Randomisation System Description document will contain full details of the cut-offs for index ulcer size and duration, and the probability that the allocation will be switched.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Universidad de Granada, University of Manchester, Gloucestershire Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, University of Birmingham, NHS Blood and Transplant
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021316
- Sponsor's protocol ID
- 19CX5371
- Acronym
- DAVE
- Status last verified
- Sep 2023
- First submitted
- 9 Jul 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing will be in line with Imperial College data sharing policy
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration
- ClinicalTrials.gov ID
- NCT04021316
- Acronym / sponsor ID
- DAVE / 19CX5371
- Conditions
- Venous Ulcer, Allograft
- Keywords
- Compression therapy, Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DMC noted that the primary end point of healed index ulcer at 12 weeks was reached only in 11.5%, whereas a higher figure of 42.5% had been used for the original power calculation, suggesting the trial is significantly underpowered.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Edinburgh, Universidad de Granada, University of Manchester, Gloucestershire Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, University of Birmingham, NHS Blood and Transplant
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 16 Jul 2019 (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.
Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone
Detailed description
Chronic venous ulceration are open wounds on the lower limbs which have been present for at least three months and are caused by a poorly functioning venous system. The affect about 1% of the general population and about 4% of those over 65. The wounds cause pain, reduced movement, and can smell - greatly affecting the quality of life of leg ulcer patients. The standard care for these patients is compression bandaging, which requires changing several times a week by community or district nurses; this drives the high cost of leg ulcer care, which can amount to £2.5 billion per annum.
Skin grafting can be used alongside compression bandaging and can help the ulcers heal faster than compression alone. Grafts can be taken from the patient's own skin, from a donor or from tissue engineered skin. An autograft (using own skin) can cause scarring and the need for a formal surgical procedure in theatre so are not suitable for all ulcer patients. Allografts (donor skin) and xenografts (animal skin) have been used successfully, but present similar drawbacks to autografts, plus the potential for the body to reject the graft and disease transmission. Tissue engineered skin has several advantages as it has been processed to remove the cells, and therefore is won't be rejected via the immune response. Human decellularised dermis (DCD) is generated from donated skin from deceased people and processed to remove the cells. It can be glued or sewn onto the skin under local anesthetic, in an out patient setting. DCD has mainly been studied in patients with diabetic foot ulceration and has shown improved healing rates and quality of life.
This study will investigate the use of DCD in addition to compression therapy versus compression therapy alone in patients with chronic venous leg ulceration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will undergo 1:1 web based randomisation to either standard care or the intervention via an automated system. A minimization algorithm using centre, index ulcer size and duration will be used, including a random component to lessen predictability. A separate Randomisation System Description document will contain full details of the cut-offs for index ulcer size and duration, and the probability that the allocation will be switched.
| Arm | Type | Receives |
|---|---|---|
| Standard care arm | Active comparator | Other: Compression bandaging therapyCompression bandaging therapy as per standard care |
| DCD Arm | Experimental | Other: dCELL® Human Dermis (decellularised dermal skin allograft - DCD), Other: Compression bandaging therapyDCD graft plus compression bandaging therapy as per standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years or older (no upper age limit)
- The ability to consent to participation
- A diagnosis of venous leg ulceration* (defined as 'colour duplex confirmation of superficial and or deep venous reflux with any break in the skin that has either: a) been present for more than 2 weeks, or b) occurred in a person with a history of venous leg ulceration)
- Documented venous incompetence on duplex ultrasound
- Index ulcer wound duration of greater than 3 months
Key exclusion criteria (6 listed)
- A diagnosis of sickle cell
- Unable to receive one or more of the randomised treatment strategies for any reason at the discretion of the attending clinical team (e.g. known allergies to dCELL dermis preparation components)
- A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
- Treatment with biomedical/topical growth factors within previous 30 days
- Previous history of an inability to tolerate compression therapy
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 |
|---|---|---|
| dCELL® Human Dermis (decellularised dermal skin allograft - DCD)DCD is produced from split thickness skin grafts (which comprise the epidermis and upper part of the dermis), and is retrieved from deceased tissue donors. All epidermal and cellular components from the dermis are removed in a patented sequential decellularisation process. As a decellularised graft, dCELL® Human Dermis fully integrates into the wound bed after application, replacing lost dermal tissue. It provides a scaffold into which the recipient's cells can grow, becoming vascularised and supporting the generation of a new epidermis, ultimately regenerating into normal skin. | Other | DCD Arm |
| Compression bandaging therapyCompression therapy will be according to local practice and may include multilayer elastic compression bandaging or stockings delivering 20 to 40mm/Hg pressure. | Other | DCD Arm, Standard care arm |
Primary outcome
Proportion with a healed index ulcer at 12 weeks after randomisation.
Time frame: 12 weeks
8 secondary outcomes
Time to index ulcer healing from randomisation
Time frame: 12 months
The percentage change in index ulcer area in cm2 at 12 weeks from randomisation
Time frame: 12 weeks
The proportion of participants with a healed index ulcer at 12 months from randomisation
Time frame: 12 months
The proportion of participants whose index ulcer healed for whom an ulcer recurred at the index site within 12 months from randomisation
Time frame: 12 months
Generic quality of life using the EuroQol-5D (EQ-5D) questionnaire
Time frame: 12 weeks, 6 months and 12 months from randomisation
Disease specific quality of life using the Charing Cross Venous Ulcer Questionnaire (CCVUQ)
Time frame: 12 weeks, 6 months and 12 months from randomisation
The cost for each patient, calculated from the healthcare resources used
Time frame: 12 months
Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis
Time frame: 12 months
Results and safety
The study was stopped early (reason given: DMC noted that the primary end point of healed index ulcer at 12 weeks was reached only in 11.5%, whereas a higher figure of 42.5% had been used for the original power calculation, suggesting the trial is significantly underpowered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No. IPD sharing will be in line with Imperial College data sharing policy
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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.
Alun H Davies principal investigator
Imperial College London
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCELL® Human Dermis (decellularised dermal skin allograft - DCD) and Compression bandaging therapy in people with Venous Ulcer and Allograft, run by Imperial College London at 17 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 was stopped early (reason given: DMC noted that the primary end point of healed index ulcer at 12 weeks was reached only in 11.5%, whereas a higher figure of 42.5% had been used for the original power calculation, suggesting the trial is significantly underpowered.). Results are not available in the source record.
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?
Proportion with a healed index ulcer at 12 weeks after randomisation. (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 28 Sep 2023.