Ischaemic skin ulcer Trials in Disease

Study on the Effectiveness of Oxygen Therapy for Patients with Diabetic Foot Ulcers

This clinical trial is investigating whether Hyperbaric Oxygen Therapy (HBOT) can help patients with diabetic foot ulcers avoid major amputations. HBOT involves breathing pure oxygen in a pressurized room or chamber, which is used alongside standard wound care. The treatment aims to increase oxygen supply to damaged tissues, promoting healing and reducing inflammation.

Who can join this study?

This trial is looking for adult participants who meet the following criteria:

• You have Type I or Type II diabetes
• You have one or more deep and infected ulcers on your lower leg or foot that have been present for at least 4 weeks or developed after a minor amputation
• Your ulcers are classified according to specific medical scales (Meggit-Wagner class 3 or 4, Texas class 2C, 3C, 2D, or 3D, or WIfI class W>1, I>1, and fI>0)
• You have reduced blood flow to your leg, confirmed by specific blood pressure measurements in your ankle or toe, or oxygen measurements in your skin
• You have undergone comprehensive imaging tests of your arteries from the main artery to the foot
• Your case has been reviewed by a team of different healthcare professionals
• You are willing to provide written consent to participate after understanding all study details

Who cannot join this study?

You will not be eligible if:

• Your wound is not related to poor blood flow caused by diabetes
• You are outside the specified age range for the study
• You belong to a vulnerable population that requires special protection

What is the goal of this trial?

The main purpose of this study is to determine whether adding HBOT to standard wound care can prevent major amputations in patients with diabetic foot ulcers. Researchers also want to find out the optimal number of therapy sessions needed to achieve the best results. Participants will receive either oxygen treatment or a placebo, and their progress will be carefully monitored.

The primary measure of success will be the rate of major amputations after 12 months of follow-up. Throughout the study, participants will undergo regular assessments to track the healing of their ulcers and overall condition.

What treatment is being tested?

The investigational treatment is Hyperbaric Oxygen Therapy (HBOT), which involves inhaling pure oxygen (delivered either in cryogenic or compressed form) in a pressurized environment. At the molecular level, this therapy works by promoting the growth of new blood vessels, reducing inflammation, and enhancing the function of white blood cells. This increased oxygen supply to the affected tissues is intended to support wound healing and tissue repair.