Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
Recruiting · NCT05132179 · Interventional (participants receive a specific treatment) · Lead sponsor: Vastra Gotaland Region
View the official record on ClinicalTrials.gov →Interventions studied
Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- NU sjukvarden - Uddevalla, Trollhattan, Sweden