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

Venous Leg Ulcers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743053
• Other study ID #: CTP003
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2012
• Last updated: June 7, 2016
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Device:
• Standard Care plus ReCell

Other:
• Standard Care

Locations

Country	Name	City	State
France	Hôpital Lapeyronie	Montpellier
United Kingdom	Bradford Teaching Hospitals	Bradford
United Kingdom	Cambridge University Hospitals - Addenbrooke's Hospital	Cambridge
United Kingdom	Cardiff University	Cardiff
United Kingdom	Doncaster and Bassetlaw Hospitals	Doncaster
United Kingdom	The Leeds Teaching Hospitals - James's University Hospital	Leeds
United Kingdom	University Hospital of South Manchester - Wythenshawe Hospital	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Avita Medical	NAMSA

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	Wounds characterization/Quality of Life	Wound area; Wound volume; Pain; Recurrence; Health-related Quality of Life	At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)	No
Secondary	Dressing Change	- Dressing change	At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed	No