NCT05132179Recruiting
Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
Source: ClinicalTrials.gov · Last updated 7 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 24 Sept 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05132179
What you commit to
- Study type: Interventional
- Planned participants: 202
- From 1 Feb 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with corticosteroids with a dose corresponding to 50 mg Prednisolon
Other illness
- 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
- 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
- Diabetes of MOODY type
Age
- Age under 18 years old
Other
- Persons in need of intensive care or dialysis
- Persons in need of vascular intervention, critically impaired circulation (toe-pressure \< 30 mm Hg)
- Planned changed residence in the coming 12 months requiring change of clinic for wound treatment during the follow-up time
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NU sjukvarden Coordinator of this site? Confirm its status | Uddevalla | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.