Study on Acetic Acid for Healing Skin Ulcers in Patients with Biofilm

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What is this study about?

This clinical trial is focused on studying the treatment of skin ulcers, which are open sores that can develop on the skin. The treatment being tested is a topical solution containing acetic acid, glacial, which is applied directly to the skin. The purpose of the study is to evaluate how effective this treatment is in helping skin ulcers heal, particularly those with a layer of bacteria known as a biofilm.

Participants in the study will receive either the acetic acid treatment or a control treatment. The study will last for a period of 8 weeks, during which the change in the size of the ulcer will be monitored. The goal is to see if the acetic acid treatment can reduce the size of the ulcer more effectively than the control treatment. The study will also look at how many participants experience complete healing of their ulcers at different points during the study, such as at 4 weeks and 12 weeks.

Throughout the study, researchers will also keep track of any side effects that participants may experience from the treatment. Additionally, the study will assess the time it takes for ulcers to heal and the associated healthcare costs. This information will help determine the overall effectiveness and safety of using acetic acid for treating skin ulcers.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes being over 18 years old, having a skin ulcer with biofilm, and the ability to participate in evaluations. Consent is required.

2 initial assessment

An initial assessment of the skin ulcer is conducted. The ulcer’s area is measured to establish a baseline for future comparisons.

3 treatment initiation

Treatment with acetic acid, glacial is started. The application is topical, meaning it is applied directly to the skin ulcer. The treatment aims to improve healing by reducing the ulcer area.

4 treatment duration

The treatment continues for a period of 8 weeks. During this time, the ulcer is monitored for changes in size and healing progress.

5 midpoint evaluation

At 4 weeks, an evaluation is conducted to assess the percentage of participants with ulcer healing. This helps to determine the treatment’s effectiveness at this stage.

6 final evaluation

After 8 weeks, a final evaluation is performed. The primary focus is on the change in ulcer area from the baseline measurement. Secondary evaluations include the time to healing and any adverse reactions.

7 extended follow-up

For some participants, follow-up may extend to 12 weeks to further assess healing progress and any long-term effects of the treatment.

Who Can Join the Study?

Patients must be over 18 years of age.
Patients should be receiving continuous care either in a hospital or as an outpatient at one of the study center units.
Patients must have a skin ulcer with biofilm. A biofilm is a group of bacteria that stick together on the skin. The ulcer should be less than 120 cm² in size and can be located anywhere on the body except the face.
Patients should be able to commit to treatment and follow-up for at least 8 weeks at the study center.
Patients must be able to participate in necessary evaluations during the study.
Patients need to provide informed consent to participate in the study. This means they agree to join the study after understanding what it involves. If the patient cannot give consent themselves, a legal representative can do it for them.

Who Cannot Join the Study?

Patients who have a skin ulcer with a biofilm. A biofilm is a group of bacteria that stick together on the surface of the ulcer, making it harder to heal.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups. The study is designed for specific groups of people.
Patients who are part of a vulnerable population. This means people who might be at higher risk of harm or who need special protection.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Consorci Sanitari De L’Alt Penedes I Garraf	Vilafranca Del Penedes	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Acetic Acid, Glacial

Acetic Acid is being tested as a topical treatment in this clinical trial. It is applied directly to skin ulcers to see if it can help improve healing. The goal is to reduce the size of the ulcers over an 8-week period. Acetic acid is known for its antibacterial properties, which may help in breaking down biofilm and promoting healing in skin ulcers.

Investigated diseases:

Skin ulcer

Skin Ulcer – A skin ulcer is an open sore or wound that develops on the skin, often due to poor blood circulation or prolonged pressure. These ulcers can occur on various parts of the body but are most commonly found on the legs, feet, and areas that experience constant pressure. The progression of a skin ulcer involves the breakdown of skin tissue, leading to an open wound that may become infected if not properly cared for. Over time, the ulcer can increase in size and depth, potentially affecting underlying tissues. Healing can be slow, especially if the ulcer is complicated by factors such as infection or the presence of a biofilm, which is a layer of bacteria that can form on the wound surface. Proper wound care and management are essential to promote healing and prevent further complications.

Trial ID:

2023-504348-32-01

Protocol code:

CSAPG-33

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Acetic Acid for Healing Skin Ulcers in Patients with Biofilm

What is this study about?

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