---
title: A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
nct_id: NCT01743053
overall_status: COMPLETED
phase: PHASE4
sponsor: Avita Medical
study_type: INTERVENTIONAL
primary_condition: Venous Leg Ulcers
countries: France, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01743053.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01743053"
ct_last_update_post_date: 2016-06-08
last_seen_at: "2026-05-12T06:25:28.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers

**NCT ID:** [NCT01743053](https://clinicaltrials.gov/study/NCT01743053)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 52
- **Lead Sponsor:** Avita Medical
- **Collaborators:** NAMSA
- **Conditions:** Venous Leg Ulcers
- **Start Date:** 2013-01
- **Completion Date:** 2015-10
- **CT.gov Last Update:** 2016-06-08

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Control: Standard Care** (OTHER) — The control group will receive standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa™ Clear).
- **ReCell** (EXPERIMENTAL) — 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).

## Interventions

- **Standard Care plus ReCell** (DEVICE)
- **Standard Care** (OTHER)

## Primary Outcomes

- **Wound healing** _(time frame: 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 Outcomes

- **Wounds characterization/Quality of Life** _(time frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks))_
- **Dressing Change** _(time frame: At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed)_

## Locations (7)

- Hôpital Lapeyronie, Montpellier, France
- 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, United Kingdom

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `locations.hôpital lapeyronie|montpellier||france` — added _(2026-05-12)_
- `locations.bradford teaching hospitals|bradford||united kingdom` — added _(2026-05-12)_
- `locations.cambridge university hospitals - addenbrooke's hospital|cambridge||united kingdom` — added _(2026-05-12)_
- `locations.cardiff university|cardiff||united kingdom` — added _(2026-05-12)_
- `locations.doncaster and bassetlaw hospitals|doncaster||united kingdom` — added _(2026-05-12)_
- `locations.the leeds teaching hospitals - james's university hospital|leeds||united kingdom` — added _(2026-05-12)_
- `locations.university hospital of south manchester - wythenshawe hospital|manchester||united kingdom` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01743053*  
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