A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers

June 7, 2016 updated by: Avita Medical
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Hopital Lapeyronie
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospitals
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals - Addenbrooke's Hospital
      • Cardiff, United Kingdom, CF24 0DE
        • Cardiff University
      • Doncaster, United Kingdom, DN2 5LT
        • Doncaster and Bassetlaw Hospitals
      • Leeds, United Kingdom, LS9 7TF
        • The Leeds Teaching Hospitals - James's University Hospital
      • Manchester, United Kingdom, M23 9LT
        • University Hospital of South Manchester - Wythenshawe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Chronic venous leg ulcer (CEAP Clinical classification of 6)

    1. Confirmed, actively managed venous reflux
    2. No exposed tendon or bone
    3. Ulcer is >4 weeks in duration
    4. Ulcer surface area between 2cm2 and 80cm2
  2. ABI ≥ 0.8
  3. The patient is 18 years of age or older
  4. The patient is willing to complete all follow-up evaluations required by the study protocol
  5. The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
  6. The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
  7. The patient is able to read and understand instructions and give voluntary written informed consent
  8. The patient is able and willing to follow the protocol requirements (including compression therapy)
  9. Patients enrolling at any site in France must have an affiliation to a social security scheme

Exclusion Criteria:

  1. Study treatment area has exposed bone or tendon
  2. Poorly controlled diabetes
  3. Arterial insufficiency (ABI < 0.8)
  4. Pregnant/lactating females (self-reported or tested, per institutional requirements)
  5. The patient has an active wound infection requiring antibiotic therapy
  6. The patient has had a prior surgical treatment of the ulcer within the past 60 days
  7. The patient has a life expectancy of 1-year or less
  8. The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
  9. The patient is unable to follow the protocol
  10. The patient is taking, or has taken in the past 60 days, mycophenolate mofetil or >10mg of corticosteroids per day.
  11. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
  12. The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
  13. The patient is a vulnerable or protected adult.
  14. The patient is unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control: Standard Care
The control group will receive standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa™ Clear).
Other: Standard Care
Experimental: ReCell
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).
Device: Standard Care plus ReCell

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wounds characterization/Quality of Life
Time Frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)
  • Wound area
  • Wound volume
  • Pain
  • Recurrence
  • Health-related Quality of Life
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
- Dressing change
At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avita Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NAMSA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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