Venous Leg UlcersPhase 4NCT01743053
A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
A Phase 4 study of Venous Leg Ulcers, run by Avita Medical at 7 sites in 2 countries.
Trial summary
This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2013to Oct 2015
- Phase
- Phase 4
- 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
- Chronic venous leg ulcer (CEAP Clinical classification of 6)
- Confirmed, actively managed venous reflux
- No exposed tendon or bone
- Ulcer is >4 weeks in duration
- Ulcer surface area between 2cm2 and 80cm2
- ABI ≥ 0.8
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- The patient is 18 years of age or older
- The patient is willing to complete all follow-up evaluations required by the study protocol
- The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
- The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
- The patient is able to read and understand instructions and give voluntary written informed consent
- The patient is able and willing to follow the protocol requirements (including compression therapy)
- Patients enrolling at any site in France must have an affiliation to a social security scheme
Who cannot join
- Study treatment area has exposed bone or tendon
- Poorly controlled diabetes
- Arterial insufficiency (ABI < 0.8)
- Pregnant/lactating females (self-reported or tested, per institutional requirements)
- The patient has an active wound infection requiring antibiotic therapy
- The patient has had a prior surgical treatment of the ulcer within the past 60 days
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- The patient has a life expectancy of 1-year or less
- The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
- The patient is unable to follow the protocol
- The patient is taking, or has taken in the past 60 days, mycophenolate mofetil or >10mg of corticosteroids per day.
- The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
- The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
- The patient is a vulnerable or protected adult.
- The patient is unable to provide consent
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United Kingdom6 sites
Bradford Teaching Hospitals
Bradford, BD9 6RJ
Cambridge University Hospitals - Addenbrooke's Hospital
Cambridge, CB2 0QQ
Cardiff University
Cardiff, CF24 0DE
Doncaster and Bassetlaw Hospitals
Doncaster, DN2 5LT
The Leeds Teaching Hospitals - James's University Hospital
Leeds, LS9 7TF
University Hospital of South Manchester - Wythenshawe Hospital
Manchester, M23 9LT
About this study
This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard care.
- Conditions
- Venous Leg Ulcers
- Being tested
- Standard Care plus ReCell, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care plus ReCellDevice
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| Control: Standard Care | Other | The control group will receive standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa™ Clear). Receives: Other: Standard Care |
| ReCell | Experimental | The ReCell group will receive ReCell in addition to standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa Clear). Receives: Device: Standard Care plus ReCell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
The primary objective of the study is to assess the difference in incidence of ulcer closure (investigator assessed as complete epithelialisation without drainage) between the ReCell group and the control group.
Measured: 12 weeks
Secondary outcomes (2)
Wounds characterization/Quality of Life
- Wound area
- Wound volume
- Pain
- Recurrence
- Health-related Quality of Life
Measured: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)
Dressing Change
- Dressing change
Measured: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avita Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743053
- Sponsor's protocol ID
- CTP003
- Status last verified
- Jun 2016
- First submitted
- 29 Nov 2012
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01743053
- Acronym / sponsor ID
- CTP003
- Conditions
- Venous Leg Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Dec 2012 (estimated)
- 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 prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Standard Care | Other | Other: Standard CareThe control group will receive standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa™ Clear). |
| ReCell | Experimental | Device: Standard Care plus ReCellThe ReCell group will receive ReCell in addition to standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa Clear). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Chronic venous leg ulcer (CEAP Clinical classification of 6)
- ABI ≥ 0.8
- The patient is 18 years of age or older
- The patient is willing to complete all follow-up evaluations required by the study protocol
- The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
Key exclusion criteria (14 listed)
- Study treatment area has exposed bone or tendon
- Poorly controlled diabetes
- Arterial insufficiency (ABI < 0.8)
- Pregnant/lactating females (self-reported or tested, per institutional requirements)
- The patient has an active wound infection requiring antibiotic 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 |
|---|---|---|
| Standard Care plus ReCell | Device | ReCell |
| Standard Care | Other | Control: Standard Care |
Primary outcome
Wound healing
Time frame: 12 weeks
The primary objective of the study is to assess the difference in incidence of ulcer closure (investigator assessed as complete epithelialisation without drainage) between the ReCell group and the control group.
2 secondary outcomes
Wounds characterization/Quality of Life
Time frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)
Dressing Change
Time frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed
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 8 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Venous Leg Ulcers, run by Avita Medical at 7 sites in 2 countries.
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 13 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 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wound healing (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 8 Jun 2016.