Trials / Completed
CompletedNCT01743053
A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard Care plus ReCell | |
| OTHER | Standard Care |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2012-12-06
- Last updated
- 2016-06-08
Locations
7 sites across 2 countries: France, United Kingdom
Source: ClinicalTrials.gov record NCT01743053. Inclusion in this directory is not an endorsement.