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

Phase 4

Completed

• Conditions: Venous Leg Ulcers
• Interventions: Other: Standard Care; Device: Standard Care plus ReCell

• Registration Number: NCT01743053
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Study Start: 2013-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Standard Care	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).
ReCell	Standard Care plus 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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Hôpital Lapeyronie; 🇫🇷 Montpellier, France

Bradford Teaching Hospitals; 🇬🇧 Bradford, United Kingdom

Cambridge University Hospitals - Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Doncaster and Bassetlaw Hospitals; 🇬🇧 Doncaster, United Kingdom

Cardiff University; 🇬🇧 Cardiff, United Kingdom

The Leeds Teaching Hospitals - James's University Hospital; 🇬🇧 Leeds, United Kingdom

University Hospital of South Manchester - Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom