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

This study is not yet open for participant recruitment.
Verified December 2012 by Avita Medical
Sponsor:
Information provided by (Responsible Party):
Avita Medical
ClinicalTrials.gov Identifier:
NCT01743053
First received: November 29, 2012
Last updated: December 4, 2012
Last verified: December 2012
  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: January 2015
Estimated Primary Completion Date: April 2014 (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)

    • Confirmed, treated venous reflux
    • No exposed tendon or bone
    • Ulcer is >4 weeks in duration
    • 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 enrollment 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)

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. Subjects who have evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) under active treatment
  6. The patient has an active wound infection requiring antibiotic therapy
  7. The patient has had a prior surgical treatment of the ulcer
  8. The patient is known to have a pre-existing condition that may interfere with wound healing, e.g. malignancy, autoimmune disease, immunocompromised blood borne diseases, the patient has AIDS, is HIV- or Hepatitis-C positive, or currently 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 medication known to have an effect on wound healing (e.g., corticosteroids)
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743053

Contacts
Contact: Samantha Hartwell, PhD 44 (0)7771 332283 SHartwell@avitamedical.com

Locations
Denmark
Odense University Hospital Not yet recruiting
Odense, Denmark
Principal Investigator: Professor Finn Gottrup         
France
Hôpital Lapeyronie Not yet recruiting
Montpellier, France
Principal Investigator: Professor Luc Téot         
United Kingdom
Addenbrookes Hospital Not yet recruiting
Cambridge, United Kingdom
Principal Investigator: Mr Paul Hayes         
Sponsors and Collaborators
Avita Medical
  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: December 4, 2012
Health Authority: United Kingdom: Research Ethics Committee
Denmark: Ethics Committee
France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on April 15, 2014