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Compares treatment options for Diabetic Foot Ulcer
Official title Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan
ClinicalTrials.gov ID: NCT05132179
What this study is testing
What is Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution?
Dakins Full Strength Solution, 0.5% Topical Solution, HOCl solution is an investigational medicine, being studied as a potential treatment for diabetic foot ulcer.
Also referred to as Dakins.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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
You likely can't join 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
See the full eligibility 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
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Uddevalla, Trollhattan, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uddevalla, Trollhattan, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.