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| Name | Class |
|---|---|
| NAMSA | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care plus ReCell | Device |
| ||
| Standard Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wounds characterization/Quality of Life |
| At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) |
| Dressing Change |
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Inclusion Criteria:
Chronic venous leg ulcer (CEAP Clinical classification of 6)
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lapeyronie | Montpellier | France | ||||
| Bradford Teaching Hospitals |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
- Dressing change
| At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed |
| Bradford |
| BD9 6RJ |
| United Kingdom |
| Cambridge University Hospitals - Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Cardiff University | Cardiff | CF24 0DE | United Kingdom |
| Doncaster and Bassetlaw Hospitals | Doncaster | DN2 5LT | United Kingdom |
| The Leeds Teaching Hospitals - James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| University Hospital of South Manchester - Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |