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

NCT01743053 | Completed Phase 4

• 1 other identifier: CTP003
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 7

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.

Conditions

Venous Leg Ulcers

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• Wounds characterization/Quality of Life

  At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)

• Dressing Change

  At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed

Study Arms (2)

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).

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).

Device: Standard Care plus ReCell

Interventions

Standard Care plus ReCell DEVICE

ReCell

Standard Care OTHER

Control: Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Avita Medical: lead
• NAMSA: collaborator

Study Sites (7)

Hôpital Lapeyronie

Montpellier, France

Location

Bradford Teaching Hospitals

Bradford, BD9 6RJ, United Kingdom

Location

Cambridge University Hospitals - Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Cardiff University

Cardiff, CF24 0DE, United Kingdom

Location

Doncaster and Bassetlaw Hospitals

Doncaster, DN2 5LT, United Kingdom

Location

The Leeds Teaching Hospitals - James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

University Hospital of South Manchester - Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 6, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

FR (1); GB (6)