Study Comparing Propylene Glycol and Urea Creams for Treating Dry Feet in People with Diabetes

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What is this study about?

This clinical trial is focused on studying the treatment of xerotic skin, which is a condition characterized by extremely dry skin, specifically on the feet of individuals with diabetes. The study will compare the effectiveness of two different skin care creams. One cream, called Oviderm, contains the active ingredient propylene glycol, and the other, known as Canoderm, contains urea. Both of these ingredients are known as humectants, which means they help to keep the skin moist by attracting water. The study will also include a comparison with a cream that does not contain any humectants.

The purpose of the study is to determine which cream is more effective in reducing the dryness of the skin on the feet of people with diabetes. Participants will apply the creams to their feet over a period of four weeks. The study will assess the severity of the dry skin using a scale called the Xerosis Severity Scale, which measures how dry the skin is. The study will also look at other factors, such as the skin’s ability to retain moisture, its hydration levels, and its pH balance, which is a measure of how acidic or basic the skin is.

Throughout the study, the safety of the creams will be monitored by documenting any side effects and checking vital signs. The study aims to provide valuable information on which cream is more effective in treating dry skin on the feet of people with diabetes, potentially leading to better management of this common condition.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent to participate.

You will need to confirm that you have a physician’s diagnosis of Diabetes Mellitus and experience dry skin on your feet. Your age must be 18 years or older, and you should be able to understand and complete the necessary forms in Swedish.

2 initial assessment

An initial assessment will be conducted to evaluate the dryness of your skin using the Xerosis Severity Scale (XSS). This scale measures the severity of dry skin on your feet.

Both feet will be assessed, and the XSS score should be between 2 and 6, with no more than a 1-point difference between the right and left foot.

3 treatment phase

You will be provided with two different creams: Oviderm and Canoderm. These creams contain active ingredients such as propylene glycol and urea.

The creams are to be applied topically, meaning directly onto the skin of your feet. You will be instructed on the dosage and frequency of application, which will be consistent throughout the study period.

4 ongoing assessments

Throughout the 4-week treatment period, regular assessments will be conducted to monitor changes in your skin condition.

These assessments will include non-invasive measurements of skin hydration, water loss, and pH levels. Your overall health and any side effects will also be monitored.

5 final evaluation

At the end of the 4-week period, a final evaluation will be conducted to assess the effectiveness of the creams in reducing skin dryness.

The results will be compared to determine which cream is more effective in treating dry skin on the feet of individuals with diabetes.

Who Can Join the Study?

Persons with a physician’s diagnosis of Diabetes Mellitus who have experienced dry skin themselves.
Dry skin on both feet with a Xerosis Severity Scale (XSS) score between 2 and 6 on both feet, with no more than 1 score unit difference between the right and left foot. Xerosis means dry skin.
Age 18 years or older.
Ability to understand and complete the necessary forms.
Sufficient knowledge of the Swedish language to understand the meaning and procedure of the study, as judged by the investigator.

Who Cannot Join the Study?

Patients who do not have xerotic skin on their feet. Xerotic skin means very dry skin.
Patients who do not have diabetes. Diabetes is a condition where the body has trouble managing blood sugar levels.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Site Name	City	Country	Status
Malmoe Universitet	Malmo	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	01.08.2023

Trial locations

Investigated drugs:

Humectant Cream A is a special type of skin cream designed to help people with diabetes who have very dry skin on their feet. This cream contains ingredients that attract and hold moisture in the skin, making it feel softer and more comfortable. The goal of using this cream is to reduce the dryness and improve the overall condition of the skin on the feet.

Humectant Cream B is another skin cream used in the study, similar to Humectant Cream A, but it contains different ingredients that also help to keep the skin moist. This cream is applied to the feet to help reduce dryness and improve skin health for people with diabetes. The study aims to see if this cream is better at treating dry skin compared to other creams.

Non-Humectant Cream is a type of skin cream that does not contain ingredients specifically designed to attract moisture. It is used in the study as a comparison to see how effective the humectant creams are in treating dry skin on the feet of people with diabetes. This cream helps researchers understand the benefits of using humectant ingredients in skin care.

Investigated diseases:

Diabetic foot

Xerosis – Xerosis, commonly known as dry skin, is a condition characterized by the skin becoming rough, scaly, and itchy. It occurs when the skin loses too much water and oil, leading to a lack of moisture. In individuals with diabetes, xerosis can be more pronounced, especially on the feet, due to impaired circulation and nerve function. The skin may crack, leading to discomfort and potential complications if not managed properly. Over time, the skin’s barrier function can weaken, making it more susceptible to irritation and infection. Regular moisturizing and care are essential to maintain skin health and prevent further progression.

Trial ID:

2022-500907-27-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Propylene Glycol and Urea Creams for Treating Dry Feet in People with Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?