Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT05132179

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

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

NU sjukvarden

Uddevalla, Trollhattan, Sweden, s-46185

Actively Recruiting

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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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