A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
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.
Venous Leg Ulcers
Device: Standard Care plus ReCell
Other: Standard Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- 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.
- 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
- 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
|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)|
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|
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|
|Contact: Samantha Hartwell, PhD||44 (0)7771 332283||SHartwell@avitamedical.com|
|Odense University Hospital||Not yet recruiting|
|Principal Investigator: Professor Finn Gottrup|
|Hôpital Lapeyronie||Not yet recruiting|
|Principal Investigator: Professor Luc Téot|
|Addenbrookes Hospital||Not yet recruiting|
|Cambridge, United Kingdom|
|Principal Investigator: Mr Paul Hayes|