Study on Sodium Hypochlorite and Polyhexamethylene Biguanide for Healing Diabetic Foot Ulcers in Patients with Diabetes

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What is this study about?

This clinical trial is focused on studying the treatment of diabetic foot ulcers, a common complication for people with diabetes where wounds on the feet do not heal properly. The study will compare two treatments: Hypochlorous Acid and Polyhexamethylene biguanide. These are both local antimicrobial agents, which means they help to prevent infection in the wound area.

The purpose of the study is to evaluate how effectively these treatments can help heal diabetic foot ulcers. Participants in the study will be randomly assigned to receive either Hypochlorous Acid or Polyhexamethylene biguanide. The study will last for up to 24 weeks, during which time the healing progress of the ulcers will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

Throughout the study, researchers will look at various factors, such as the time it takes for the ulcers to heal completely, changes in the size and depth of the ulcers, and the overall quality of life of the participants. The goal is to determine which treatment is more effective in promoting healing and improving the well-being of individuals with diabetic foot ulcers.

1 joining the trial

Upon joining the trial, informed consent is required. This involves understanding the trial’s purpose and agreeing to participate.

Eligibility criteria include having diabetes (type 1, type 2, or due to pancreatitis), a foot ulcer present for at least 10 days, an ulcer surface area of at least 9 mm², and being 18 years or older.

2 randomization and baseline assessment

Participants are randomly assigned to one of two treatment groups: one receiving Hypochlorous Acid (HOCl) and the other receiving Polyhexamethylene biguanide (PHMB).

Baseline assessments are conducted to evaluate the initial condition of the diabetic foot ulcer (DFU).

3 treatment phase

The treatment involves the application of the assigned antimicrobial agent to the ulcer. The route of administration is cutaneous, meaning it is applied directly to the skin.

The treatment duration is up to 24 weeks, with regular monitoring and assessments to track healing progress.

4 midpoint evaluation

At week 12, an evaluation is conducted to assess the proportion of healed DFUs in each treatment group.

Changes in the surface area and depth of the DFU are measured and compared between the two groups.

5 final assessment

At the end of the 24-week treatment period, a final assessment is conducted to evaluate the time to healing and other secondary outcomes.

These outcomes include changes in the quality of life, measured using the EQ5-D questionnaire, and the number of days antibiotics were needed.

Who Can Join the Study?

You must provide written and spoken agreement to participate in the study before any study-related activities begin.
You must have diabetes, which can be type 1, type 2, or diabetes caused by pancreatitis (a condition where the pancreas becomes inflamed).
You must have a foot ulcer that has been present for 10 days or more. A foot ulcer is an open sore or wound on the foot.
The ulcer must have a surface area of at least 9 square millimeters. This means the sore should be at least this size.
You must be 18 years old or older.

Who Cannot Join the Study?

Patients who have a severe infection that has spread beyond the foot.
Patients with a history of poor blood flow to the legs and feet, which is not being treated.
Patients who have had a recent surgery on the foot or leg.
Patients with a known allergy to the treatment being tested in the study.
Patients who are currently participating in another clinical trial.
Patients who are unable to follow the study procedures or attend follow-up visits.
Patients with a medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Vaestra Goetalandsregionen	Vänersborg	Sweden
Region Stockholm – SLSO	Stockholm	Sweden
Region Dalarna	Falun	Sweden
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Region Soermland	Nykoping	Sweden
Region Uppsala	Uppsala	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden
Region Kronoberg	Vaxjo	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Halland	Varberg	Sweden
Capio Närvård AB	Simrishamn	Sweden
Capio Legevisitten AB	Stocksund	Sweden
Region Skane Angelholms Sjukhus	Helsingborg	Sweden
Lsutoazjqx I Mkfebd Rsnopl Oqwvjpksdroj	Motala	Sweden
Shjgqyfjq I Vxdvwryihvykvky Gxqqsdsevjyvvjnivd	Angered	Sweden
Fymwjegnkklapp i Sxzvgrflqrae Aa	Saltsjöbaden	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	09.12.2021

Trial locations

Investigated drugs:

Sodium Hypochlorite

Hypochlorous Acid is being tested in this trial for its ability to help heal diabetic foot ulcers. It is an antimicrobial agent, which means it helps to kill or stop the growth of bacteria and other microorganisms that can cause infections. The goal is to see if it can speed up the healing process of the ulcers.

Polyhexamethylene Biguanide is another antimicrobial agent used in this trial. It is known for its effectiveness in preventing infections by killing bacteria and other harmful microorganisms. The trial aims to determine if it can help diabetic foot ulcers heal faster compared to other treatments.

Diabetic Foot Ulcer – Diabetic foot ulcer is a common complication of diabetes, characterized by an open sore or wound that occurs on the foot. It typically develops due to a combination of factors such as poor circulation, nerve damage, and high blood sugar levels. The ulcer can start as a small blister or cut and may progress to a larger, more serious wound if not properly managed. Over time, the ulcer can become infected, leading to further complications. The healing process can be slow, especially if blood sugar levels are not well controlled. Regular monitoring and care are essential to prevent the ulcer from worsening.

Trial ID:

2024-512612-22-00

Protocol code:

Dakin´s – Diabetes

NCT ID:

NCT05132179

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Sodium Hypochlorite and Polyhexamethylene Biguanide for Healing Diabetic Foot Ulcers in Patients with Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?