Clinical trial NCT01743053: A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Leg Ulcers
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2012-12-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Wound healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Wounds characterization/Quality of Life
timeFrame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)
measure: Dressing Change
timeFrame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Lapeyronie
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals - Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Hospitals
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals - James's University Hospital
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester - Wythenshawe Hospital
Study officials:
References: