Back to resultsA Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
Primary Purpose
Venous Leg Ulcers
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Standard Care plus ReCell
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcers
Eligibility Criteria
Inclusion Criteria:
Chronic venous leg ulcer (CEAP Clinical classification of 6)
- Confirmed, actively managed venous reflux
- No exposed tendon or bone
- Ulcer is >4 weeks in duration
- Ulcer surface area between 2cm2 and 80cm2
- ABI ≥ 0.8
- The patient is 18 years of age or older
- The patient is willing to complete all follow-up evaluations required by the study protocol
- The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
- The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
- The patient is able to read and understand instructions and give voluntary written informed consent
- The patient is able and willing to follow the protocol requirements (including compression therapy)
- Patients enrolling at any site in France must have an affiliation to a social security scheme
Exclusion Criteria:
- Study treatment area has exposed bone or tendon
- Poorly controlled diabetes
- Arterial insufficiency (ABI < 0.8)
- Pregnant/lactating females (self-reported or tested, per institutional requirements)
- The patient has an active wound infection requiring antibiotic therapy
- The patient has had a prior surgical treatment of the ulcer within the past 60 days
- The patient has a life expectancy of 1-year or less
- The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
- The patient is unable to follow the protocol
- The patient is taking, or has taken in the past 60 days, mycophenolate mofetil or >10mg of corticosteroids per day.
- The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
- The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
- The patient is a vulnerable or protected adult.
- The patient is unable to provide consent
Sites / Locations
- Hôpital Lapeyronie
- Bradford Teaching Hospitals
- Cambridge University Hospitals - Addenbrooke's Hospital
- Cardiff University
- Doncaster and Bassetlaw Hospitals
- The Leeds Teaching Hospitals - James's University Hospital
- University Hospital of South Manchester - Wythenshawe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control: Standard Care
ReCell
Arm Description
The control group will receive standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa™ Clear).
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).
Outcomes
Primary Outcome Measures
Wound healing
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
Wounds characterization/Quality of Life
Wound area
Wound volume
Pain
Recurrence
Health-related Quality of Life
Dressing Change
- Dressing change
Full Information
NCT ID
NCT01743053
First Posted
November 29, 2012
Last Updated
June 7, 2016
Sponsor
Avita Medical
Collaborators
NAMSA
1. Study Identification
Unique Protocol Identification Number
NCT01743053
Brief Title
A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avita Medical
Collaborators
NAMSA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control: Standard Care
Arm Type
Other
Arm Description
The control group will receive standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa™ Clear).
Arm Title
ReCell
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Standard Care plus ReCell
Intervention Type
Other
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Wound healing
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Wounds characterization/Quality of Life
Description
Wound area
Wound volume
Pain
Recurrence
Health-related Quality of Life
Time Frame
At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)
Title
Dressing Change
Description
- Dressing change
Time Frame
At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic venous leg ulcer (CEAP Clinical classification of 6)
Confirmed, actively managed venous reflux
No exposed tendon or bone
Ulcer is >4 weeks in duration
Ulcer surface area between 2cm2 and 80cm2
ABI ≥ 0.8
The patient is 18 years of age or older
The patient is willing to complete all follow-up evaluations required by the study protocol
The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
The patient is able to read and understand instructions and give voluntary written informed consent
The patient is able and willing to follow the protocol requirements (including compression therapy)
Patients enrolling at any site in France must have an affiliation to a social security scheme
Exclusion Criteria:
Study treatment area has exposed bone or tendon
Poorly controlled diabetes
Arterial insufficiency (ABI < 0.8)
Pregnant/lactating females (self-reported or tested, per institutional requirements)
The patient has an active wound infection requiring antibiotic therapy
The patient has had a prior surgical treatment of the ulcer within the past 60 days
The patient has a life expectancy of 1-year or less
The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
The patient is unable to follow the protocol
The patient is taking, or has taken in the past 60 days, mycophenolate mofetil or >10mg of corticosteroids per day.
The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
The patient is a vulnerable or protected adult.
The patient is unable to provide consent
Facility Information:
Facility Name
Hôpital Lapeyronie
City
Montpellier
Country
France
Facility Name
Bradford Teaching Hospitals
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Cambridge University Hospitals - Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Cardiff University
City
Cardiff
ZIP/Postal Code
CF24 0DE
Country
United Kingdom
Facility Name
Doncaster and Bassetlaw Hospitals
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals - James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University Hospital of South Manchester - Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
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