Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510777
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
PICO Venous Leg Ulcers VLU Reimbursement Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pragmatic Multi-centre Prospective Randomized Superiority Study to Compare the Performance of the Single-use Negative Pressure Wound Therapy System PICO Versus Standard of Care in the Management of Venous Leg Ulcers
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks versus Standard of Care SOC in the treatment of hard to heal Venous Leg Ulcers VLU by community-based practitioners The primary endpoint is the incidence of confirmed healed VLUs at 12 weeks or before in the PICO treatment group versus the SOC group The study hypothesis is based on the Kirsner study Kirsner R Dove C Reyzelman A Vayser D Jaimes H A prospective randomized controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities Wound Repair Regen 2019 Sep275519-529 which compared PICO treatment to traditional NPWT t-NPWT the ITT analysis in the subgroup of patients with VLU showed 451 wound closure confirmed wound healing at 12 weeks in the PICO group as compared to 28 in the t-NPWT group yielding a difference of 171 95 Confidence Interval -19354 For our study the Sponsor made the assumptions that the t-NPWT healing proportion 28 can be used as conservative estimate for the control group proportion and that the PICO group should provide at least a 17 improvement over standard of care Adaptative design is chosen to adjust the sample size using the re-assessment size method to preserve alpha risk α level
Detailed Description:
This is a national multicentre pragmatic randomized controlled superiority study in which PICO treatment with compression therapy will be compared against Standard of Care ie traditional wound dressings with compression therapy There will be two parallel treatment arms with a 11 allocation ratio and a stratification on wound duration and size There will be an additional blind assessment for the primary outcome measure
Approximately 37 investigational sites located in France will be enrolled At each site a community-based practitioner general practitioner or specialist will be enrolled as Principal Investigator PI District nurses will be responsible for providing wound care in homecare setting Duly informed and eligible patients will complete an inclusion visit after which they will enter in a 2-week run-in period in which subjects will be treated with standard of care After these 2 weeks of run-in eligibility to randomization will be assessed using pre-specified criteria listed in the protocol that aim to confirm that the wound does not respond to an adequately conducted standard of care in a satisfactory manner including subject compliance with compression therapy
Upon randomization baseline data will be collected and each subject will be followed-up by the PI for 12 weeks The PI will conduct 3 visits ie at Week 4 D283 days Week 8 D563 days and Week 12 D843 days Relevant study data will be collected at these visits In the event wound healing is observed during the 12-week follow-up period of the study either by the PI or by the home care nurse a Wound Healing Confirmation Visit needs to be conducted with the PI 2 weeks later 3 days to confirm that the wound is still healed Only wounds still healed at the wound healing confirmation visit will be counted as healed in the primary endpoint analysis This means that for wounds that are not healed by Week 12 the visit with the PI at Week 12 will be the final study visit for the subject Following because a Wound Healing Confirmation Visit needs to be conducted 2 weeks 3 days following the initial observation of wound healing which can occur at any time throughout the 12 week follow-up period the Wound Healing Confirmation Visit can occur at any time as well but at the latest 2 weeks 3 days following the visit at Week 12 ie at week 143 days
In between study visits with the PI patients are cared for at home by their home care nurse who will also be trained on the study The study nurse will be collecting study related data as well using a secure mobile application
Approximately 37 investigational sites located in France will be enrolled At each site a community-based practitioner general practitioner or specialist will be enrolled as Principal Investigator PI District nurses will be responsible for providing wound care in homecare setting Duly informed and eligible patients will complete an inclusion visit after which they will enter in a 2-week run-in period in which subjects will be treated with standard of care After these 2 weeks of run-in eligibility to randomization will be assessed using pre-specified criteria listed in the protocol that aim to confirm that the wound does not respond to an adequately conducted standard of care in a satisfactory manner including subject compliance with compression therapy
Upon randomization baseline data will be collected and each subject will be followed-up by the PI for 12 weeks The PI will conduct 3 visits ie at Week 4 D283 days Week 8 D563 days and Week 12 D843 days Relevant study data will be collected at these visits In the event wound healing is observed during the 12-week follow-up period of the study either by the PI or by the home care nurse a Wound Healing Confirmation Visit needs to be conducted with the PI 2 weeks later 3 days to confirm that the wound is still healed Only wounds still healed at the wound healing confirmation visit will be counted as healed in the primary endpoint analysis This means that for wounds that are not healed by Week 12 the visit with the PI at Week 12 will be the final study visit for the subject Following because a Wound Healing Confirmation Visit needs to be conducted 2 weeks 3 days following the initial observation of wound healing which can occur at any time throughout the 12 week follow-up period the Wound Healing Confirmation Visit can occur at any time as well but at the latest 2 weeks 3 days following the visit at Week 12 ie at week 143 days
In between study visits with the PI patients are cared for at home by their home care nurse who will also be trained on the study The study nurse will be collecting study related data as well using a secure mobile application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None