Actively Recruiting
Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
Led by Vastra Gotaland Region · Updated on 2024-05-07
202
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before any trial activities
- Diagnosed with Diabetes Mellitus type 1, type 2, or diabetes due to pancreatitis
- Have had a foot ulcer for 3 weeks or longer
- Foot ulcer has a surface area of 9 mm² or more
- Age 18 years or older
You will not qualify if you...
- Require intensive care or dialysis
- Need vascular intervention or have critically impaired circulation (toe-pressure less than 30 mm Hg)
- Experienced a heart attack or stroke in the last 3 months
- Developed atrial fibrillation or heart failure in the last 3 months
- Currently receiving treatment for cancer
- Taking corticosteroids equal to 50 mg Prednisolone or more
- Have severe wound infection with at least two signs: body temperature below 36°C or above 38°C, heart rate over 90/min, respiration rate over 20/min, or high white blood cell count
- Planning to change residence within 12 months requiring a change of wound treatment clinic
- Under 18 years old
- Have MOODY type diabetes
- Currently pregnant or planning pregnancy in the next 26 weeks
- Participating in another clinical trial for any treatment
- Other reasons the investigator decides the patient is unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NU sjukvarden
Uddevalla, Trollhattan, Sweden, s-46185
Actively Recruiting
Research Team
K
Karin Bergqvist, MD
CONTACT
M
Marcus Lind, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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