Venous Leg Ulcers
Conditions
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.
Interventions
DEVICEStandard Care plus ReCell
OTHERStandard Care
Sponsors
NAMSA
Avita Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 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
| Measure | Time frame | Description |
|---|---|---|
| Wounds characterization/Quality of Life | 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 |
| Dressing Change | At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed | \- Dressing change |
Countries
France, United Kingdom
Outcome results
None listed