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

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with Symptomatic Ischemic Ulcers related to Diabetes. The treatment being tested is called Hyperbaric Oxygen Therapy (HBOT), which involves breathing pure oxygen in a pressurized room or chamber. This therapy is being used in addition to standard wound care to see if it can help prevent major amputations in patients with these types of ulcers.

The purpose of the study is to determine whether HBOT is effective in treating these ulcers and to find out the best number of therapy sessions needed to achieve the desired effect. Participants in the study will receive either the oxygen treatment or a placebo, and their progress will be monitored over a period of time. The study will look at the rate of major amputations after 12 months to assess the effectiveness of the treatment.

During the study, participants will undergo regular assessments to monitor their condition and the healing of their ulcers. The treatment involves inhaling Oxygen as a medicinal gas, either in a cryogenic or compressed form, through inhalation. The study aims to provide valuable information on whether adding HBOT to standard care can improve outcomes for patients with diabetic ulcers.

1 joining the study

Participation begins after meeting specific criteria, including having Type I or II diabetes and one or more deep, clinically infected lower extremity ulcers.

A complete assessment of peripheral arterial lesions is required, using various imaging techniques.

Inclusion follows a multidisciplinary consultation and signing of a written informed consent.

2 treatment phase

The treatment involves the use of oxygen administered through inhalation.

The study aims to evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) as an additional treatment to standard wound care.

The goal is to prevent major amputations and determine the optimal number of sessions needed.

3 follow-up

The primary endpoint is the rate of major amputations after a 12-month follow-up period.

Regular monitoring and assessments are conducted to evaluate the progress and effectiveness of the treatment.

Who Can Join the Study?

You must have Type I or Type II diabetes.
You need to have one or more deep and infected ulcers on your lower leg or foot. These ulcers should be classified as Meggit-Wagner class 3 or 4, Texas class 2C, 3C, 2D, or 3D, or WIfI class W>1, I>1, and fI>0. The ulcers should have been present for at least 4 weeks or appeared after a minor amputation due to a previous ulcer.
You must have leg ischemia, which means reduced blood flow to the leg. This is shown by an ankle blood pressure less than 70 mmHg, a toe blood pressure less than 50 mmHg, or a TcpO2 less than 40 mmHg.
A complete check of your arteries from the main artery (aorta) to the foot arteries must be done using special imaging tests like duplex ultrasonography, magnetic resonance angiography, computed tomography angiography, or intraarterial digital subtraction angiography.
You need to be discussed and included in the study after a multidisciplinary consultation, which means a team of different healthcare professionals will review your case.
You must be an adult.
You need to provide written informed consent, which means you agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who do not have a symptomatic ischemic ulcer related to diabetes. This means the wound is not caused by poor blood flow due to diabetes.
Patients who are not within the specified age range for the study.
Patients who are not part of the clinical trial group being studied.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Alrijne Zorggroep Stichting	Leiderdorp	The Netherlands
Ikazia Ziekenhuis	Rotterdam	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands
Armwsgnaw Udh	Amsterdam	The Netherlands
Holttfgu dx Pqxsvot	Palamós	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.09.2020
The Netherlands	Not recruiting	01.09.2020

Trial locations

Investigated drugs:

Oxygen

HBOT (Hyperbaric Oxygen Therapy) is a treatment that involves breathing pure oxygen in a pressurized room or chamber. It is used in this trial as an additional therapy to standard wound care for patients with ischemic diabetic foot ulcers (DFU). The goal is to see if this therapy can help prevent major amputations by improving the healing of the ulcers. The study aims to determine how effective HBOT is and to find out the best number of sessions needed to achieve the desired results.

Investigated diseases:

Diabetic Foot Ulcer – A diabetic foot ulcer is an open sore or wound that occurs in approximately 15% of patients with diabetes and is commonly located on the bottom of the foot. It develops due to a combination of factors, such as lack of feeling in the foot, poor circulation, foot deformities, irritation, and trauma, as well as duration of diabetes. The progression of the ulcer can be slow, and it may become infected if not properly managed. Over time, the ulcer can lead to more severe complications, including tissue damage and the risk of amputation. Proper foot care and monitoring are essential to prevent the development and worsening of these ulcers.

Trial ID:

2024-511743-26-00

NCT ID:

NCT05804097

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?