NCT05804097

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Peripheral Vascular Disease
• Diabetic Foot Ulcer
• Amputation

Interventions

Type	Name	Description
DRUG	Hyperbaric oxygen	90-120 min sessions of hyperbaric oxygen treatment of 2.2-2.5 ATA

Timeline

• Start date: 2021-10-08
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2023-04-07
• Last updated: 2024-11-08

Locations

1 site across 1 country: Netherlands