Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05804097
Status:
RECRUITING
Last Update Posted:
2023-04-07
First Post:
2023-03-24
Brief Title:
Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIONYSIUS
Brief Summary:
The goal of this multicenter multi-national multi-arm multi-stage randomized controlled trial is to determine the added benefit of hyperbaric oxygen treatment HBOT in patients with diabetic foot ulcers and peripheral vascular disease The main question is
- What is the difference is the major amputation rate between the study arms
Participants will be randomized to 20 30 or 40 sessions of HBOT or a control group
- What is the difference is the major amputation rate between the study arms
Participants will be randomized to 20 30 or 40 sessions of HBOT or a control group
Detailed Description:
Objective The primary objective is to assess the cost- effectiveness of HBOT in addition to standard wound care and vascular surgical treatment for patients with a DFU and leg ischaemia
Study design An international multi-arm multi-stage MAMS design is chosen to conduct an efficient randomised clinical trial At a planned interim analysis the best performing study arms will be chosen to continue
Study population We need up to 544 patients with a Meggitt-Wagner stage 3 or 4 DFU and proven peripheral ischaemia
Intervention Patients will be randomised to receive standard care wound treatment and surgical interventions following international guidelines with either 0 20 30 or at least 40 sessions of HBOT These sessions will compromise 90-120 minutes of HBOT at a pressure of 22-25 ATA according to international standards
Main study parametersendpoints The primary endpoint is major amputation rate after 12 months Secondary objectives are amputation-free survival wound healing health-related quality of life and cost-effectiveness of the interventions
Study design An international multi-arm multi-stage MAMS design is chosen to conduct an efficient randomised clinical trial At a planned interim analysis the best performing study arms will be chosen to continue
Study population We need up to 544 patients with a Meggitt-Wagner stage 3 or 4 DFU and proven peripheral ischaemia
Intervention Patients will be randomised to receive standard care wound treatment and surgical interventions following international guidelines with either 0 20 30 or at least 40 sessions of HBOT These sessions will compromise 90-120 minutes of HBOT at a pressure of 22-25 ATA according to international standards
Main study parametersendpoints The primary endpoint is major amputation rate after 12 months Secondary objectives are amputation-free survival wound healing health-related quality of life and cost-effectiveness of the interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None