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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Avita Medical
Sponsor:
Collaborator:
NAMSA
Information provided by (Responsible Party):
Avita Medical
ClinicalTrials.gov Identifier:
NCT01743053
First received: November 29, 2012
Last updated: February 19, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Venous Leg Ulcers
Device: Standard Care plus ReCell
Other: Standard Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Avita Medical:

Primary Outcome Measures:
  • Wound healing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Wounds characterization/Quality of Life [ Time Frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) ] [ Designated as safety issue: No ]
    • Wound area
    • Wound volume
    • Pain
    • Recurrence
    • Health-related Quality of Life

  • Dressing Change [ Time Frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed ] [ Designated as safety issue: No ]
    - Dressing change


Estimated Enrollment: 65
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743053

Contacts
Contact: Julie Trim, PhD 44 (0) 1763 269770 jtrim@avitamedical.com

Locations
France
Hôpital Lapeyronie Completed
Montpellier, France
United Kingdom
Bradford Teaching Hospitals Recruiting
Bradford, United Kingdom, BD9 6RJ
Contact: Wendy Jepson       Wendy.Jepson@bthft.nhs.uk   
Principal Investigator: Mr Kevin Mercer         
Cambridge Univeristy Hospitals - Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Penny Shipley-Cribb       penny.shipley-crib@addenbrookes.nhs.uk   
Principal Investigator: Mr Paul Hayes         
Cardiff University Recruiting
Cardiff, United Kingdom, CF24 0DE
Contact: Nicola Ivins       ivinsnm@cf.ac.uk   
Principal Investigator: Professor Keith Harding         
Doncaster and Bassetlaw Hospitals Recruiting
Doncaster, United Kingdom, DN2 5LT
Contact: Nicola Lancaster       nicola.lancaster@dbh.nhs.uk   
Principal Investigator: Sue Johnson         
The Leeds Teaching Hospitals - James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Janet Woods       Janet.Woods@leedsth.nhs.uk   
Principal Investigator: Mr David Russell         
University Hospital of South Manchester - Wythenshawe Hospital Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Sarah Sahin       Sarah.sahin@UHSM.NHS.UK   
Principal Investigator: Professor Charles McCollum         
Sponsors and Collaborators
Avita Medical
NAMSA
  More Information

No publications provided

Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT01743053     History of Changes
Other Study ID Numbers: ReCell VLU Pilot Study
Study First Received: November 29, 2012
Last Updated: February 19, 2015
Health Authority: United Kingdom: National Health Service
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Cardiovascular Diseases
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on April 26, 2015