Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan

Recruiting now · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID: NCT05132179
Run by: Vastra Gotaland Region
People needed: 202
Starts: 2022-02-01
Expected to finish: 2026-12-31
Last updated by the study team: 2024-05-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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

NU sjukvarden — Uddevalla, Trollhattan, Sweden (enrolling)

Full record on ClinicalTrials.gov

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