Diabetic Foot Ulcer Clinical Trial
Official title:
A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
202 Diabetic foot ulcers will be cleaned with either Hypochlorous Acid, HClO or Polyhexamethylene biguanide, PHMB twice a week until healed or 24 weeks. Primary objective is to find out if cleaning DFU with HClO is more effective in obtaining complete healing than PHMB.
Status | Recruiting |
Enrollment | 202 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | NU sjukvarden | Uddevalla | Trollhattan |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to healing | The primary efficacy analysis of difference in time to healing from randomisation up to 24 weeks between the two randomised groups. Analysis will be performed using Cox regression. The healing date will be defined as the first visit when the ulcer is fully covered with skin. | 24 weeks | |
Secondary | Proportion of DFU that heals within 12 weeks of treatment | Difference in proportion healed DFU between groups at week 12 will be estimated using Fisher´s exact test | 12 weeks | |
Secondary | Change of DFU´s surface area | The size of surface area measured with a mm ruler in photo of the DFU. The surface area of The DFU will be measured weekly for 24 weeks or until healed from weekly photo with a mm ruler in the photo. The calculation of the area will be done by a person not involved in the treatment. For each participants and time point, the percentage change of the ulcer size (area and volume) will be calculated in relation to randomisation. For each group (HOCl and PHMB, respectively), the average change in ulcer size (area and volume) will be calculated, whereafter any difference between the two groups will be examined for statistical significance. | 24 weeks | |
Secondary | Change of diabetic foot ulcer´s, DFU´s, depth | The depth of diabetic foot ulcer measured with digital pair of calipers weekly for 24 weeks or until healed. For each participant and time point, the percentage change of the ulcer size (area and volume) will be calculated in relation to the date of randomisation. For each group (HOCl and PHMB, respectively), the average change in ulcer size (area and volume) will be calculated, whereafter any difference between the two groups will be examined for statistical significance. | 24 weeks |
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