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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01743053
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : June 8, 2016
Information provided by (Responsible Party):
Avita Medical

Brief 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. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard care.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcers Device: Standard Care plus ReCell Other: Standard Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. Dressing Change [ Time Frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed ]
    - Dressing change

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01743053

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Hôpital Lapeyronie
Montpellier, France
United Kingdom
Bradford Teaching Hospitals
Bradford, United Kingdom, BD9 6RJ
Cambridge University Hospitals - Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Cardiff University
Cardiff, United Kingdom, CF24 0DE
Doncaster and Bassetlaw Hospitals
Doncaster, United Kingdom, DN2 5LT
The Leeds Teaching Hospitals - James's University Hospital
Leeds, United Kingdom, LS9 7TF
University Hospital of South Manchester - Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Avita Medical
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Responsible Party: Avita Medical Identifier: NCT01743053    
Other Study ID Numbers: CTP003
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases