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.
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 arm(s) 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 2.2-2.5 ATA according to international standards. Main study parameters/endpoints: 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
90-120 min sessions of hyperbaric oxygen treatment of 2.2-2.5 ATA
Amsterdam UMC
Amsterdam, Noord-Hollad, Netherlands
Major Amputations
Major amputations, defined as below the knee or above the knee amputations
Time frame: 12 months after inclusion
Amputation-free survival
Time without amputation
Time frame: Complete follow-up (up to 3 years)
Health-related quality of life
Quality of life based on various questionnaires (objective)
Time frame: Complete follow-up (up to 3 years)
Complete wound healing
Complete wound healing
Time frame: 12 months after inclusion
Pain scores
Pain scores taken by VAS questionnaire
Time frame: 12 months after inclusion
Need for additional (vascular) interventions
Vascular interventions performed during time of inclusion
Time frame: Complete follow-up (up to 3 years)
Cost-effectiveness and budget impact
Costs of healthcare resources, including HBOT, related to the total number of eligible patients for HBOT per year. QALYs, based on EQ-5D-5L
Time frame: Complete follow-up (up to 3 years)
Mortality
Mortality
Time frame: Complete follow-up (up to 3 years)
Patients perception of improvement
Quality of life based on various questionnaires (subjective)
Time frame: Complete follow-up (up to 3 years)
TcpO2 before, during and after HBOT
Measurements of TcpO2 surrounding HBOT treatment
Time frame: During intervention period
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