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A randomized double-blind clinical trial comparing Hypochlorous Acid and Polyhexamethylene biguanide in treating diabetic foot ulcers
EU CTIS ID: 2024-512612-22-00
What this study is testing
The primary aim of this trial is to evaluate time to healing. This means to evaluate the efficiency of local antimicrobial agents to bring about complete healing of DFU, diabetic foot ulcer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written and verbal informed consent given before trial-related activities
- Diabetes type 1, type 2 or diabetes due to pancreatitis
- Foot ulcer ≥ 10 days
- Ulcer surface area ≥ 9 mm2
- Age 18 years old or older
You likely can't join if
- Persons in need of intensive care or dialysis.
- Debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks.
- Treatment with corticosteroids of a dose corresponding to 50 mg Prednisolone or higher.
- Severe wound infection according to the International Working Group of the Diabetic Foot comprising at least 2 of the following signs: body temperature>38°C or <36°C, heart rate >90 beats/minute, respiration rate >20/minute, LPK>12 x 10^9
- Planned changed residence within the next 26 weeks requiring change of clinic for wound treatment during the follow-up time.
- Age <18 years old.
See the full eligibility criteria
- Written and verbal informed consent given before trial-related activities
- Diabetes type 1, type 2 or diabetes due to pancreatitis
- Foot ulcer ≥ 10 days
- Ulcer surface area ≥ 9 mm2
- Age 18 years old or older
- Persons in need of intensive care or dialysis.
- Debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks.
- Treatment with corticosteroids of a dose corresponding to 50 mg Prednisolone or higher.
- Severe wound infection according to the International Working Group of the Diabetic Foot comprising at least 2 of the following signs: body temperature>38°C or <36°C, heart rate >90 beats/minute, respiration rate >20/minute, LPK>12 x 10^9
- Planned changed residence within the next 26 weeks requiring change of clinic for wound treatment during the follow-up time.
- Age <18 years old.
- If the toe or foot where the DFU is located likely needs amputation in close future or will undergo a spontaneous amputation or need judgement regarding this risk of amputation by further specialist (o.e. the DFU will not be possible to evaluate regarding healing effects)
- Diabetes of MOODY type.
- Current known pregnancy or planned pregnancy during the next 26 weeks by asking the participant.
- For participation in the sub study of 40 patients taking biopsies the DFU shall not be close to a joint, have direct skeletal contact or risk that such an appear and the DFU should not be ground with granular healing tissue.
- Participation in another trial evaluating any treatment.
- Other reasons judged by the investigator that the patient is unsuitable for participation in the study.
- Persons in need of vascular intervention, critically impaired peripheral circulation (toe pressure < 30 mmHg).
- Current treatment of malignancy.
- Event of myocardial infarction or stroke during the last 4 weeks.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.