Comparing two treatments for diabetic foot ulcers
A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
This study is testing which wound cleaner, Hypochlorous Acid or Polyhexamethylene biguanide, works better for healing diabetic foot ulcers in people over a period of up to 24 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Uddevalla, Trollhattan) |
| Trial ID | NCT05132179 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diabetes and foot ulcers that have persisted for three weeks or more.
Not a fit: Patients with severe complications such as critically impaired circulation, recent myocardial infarction or stroke, or those requiring intensive care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for diabetic foot ulcers, improving healing rates and patient outcomes.
How similar studies have performed: Previous studies have shown varying degrees of success with similar antimicrobial treatments, but this specific comparison of HClO and PHMB is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Uddevalla, Trollhattan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.