Comparing two treatments for diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves 202 participants with diabetic foot ulcers who will be randomly assigned to receive either Hypochlorous Acid (HClO) or Polyhexamethylene biguanide (PHMB) for cleaning their wounds. The treatment will occur twice a week until the ulcers heal or for a maximum of 24 weeks. The primary goal is to determine which cleaning agent is more effective in achieving complete healing of the ulcers, while secondary objectives include assessing healing time, ulcer size, depth, antibiotic use, and quality of life. The study is designed to be double-blind and controlled to ensure unbiased results.

Why it matters

Who can join: the full rules

Inclusion Criteria: Informed consent obtained before trial-related activities,

* Diabetes Mellitus type 1 or 2 or due to pancreatitis
* Foot ulcer since 3 weeks or more
* Ulcer surface area 9 mm2 or more
* Age 18 years old or more

Exclusion Criteria:

* Persons in need of intensive care or dialysis
* Persons in need of vascular intervention, critically impaired circulation (toe-pressure \< 30 mm Hg)
* Event of myocardial infarction or stroke during the last three months
* Debut of atrial fibrillation or heart failure during the last three months
* Current treatment of malignancy
* Treatment with corticosteroids with a dose corresponding to 50 mg Prednisolon
* Severe wound infection according to International Working Group of Diabetic Foot, IWGDF at least two of following signs: body temperature \<36 C or \>38 C, heart rate \>90/minute, respiration rate \>20/minute, LPK \>12x10\^9/L
* Planned changed residence in the coming 12 months requiring change of clinic for wound treatment during the follow-up time
* Age under 18 years old
* Diabetes of MOODY type
* Current known pregnancy or planned pregnancy next 26 weeks
* Participation in another clinical trial evaluating any treatment
* Other reasons judged by the investigator that the patient is unsuitable for participation in the study

Where it's running

• NU sjukvarden
  Uddevalla, Trollhattan, Sweden Recruiting

Study contacts

• Principal investigator: Marcus Lind, Prof — University of Gothenburg, Sahlgrenska Academy
• Study coordinator: Karin Bergqvist, MD
• Email: karin.bergqvist@vgregion.se
• Phone: +46730961700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Transverse tibial bone transport to help heal chronic diabetic foot ulcers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.