A Randomized Double-blind Clinical Trial Comparing Hypochlorous Acid and Polyhexamethylene Biguanide in Treating Diabetic Foot Ulcers
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Sweden
NU sjukvarden
RECRUITING
Uddevalla
Contact Information
Primary
Karin Bergqvist, MD
karin.bergqvist@vgregion.se
+46730961700
Backup
Marcus Lind, Prof
lind.marcus@telia.com
+46700824239
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 202
Treatments
Active_comparator: HOCl arm
Dakin´s Solution, with the active substance Hypochlorous Acid, HOCl was first invented 1915 for use on infected war wounds. The DFU will be cleaned with HOCl twice a week. The treatment will be performed in accordance with instructions for Prontosan, PHMB.
No_intervention: PHMB arm
Prontosan, with the active substance PHMB, is recommended by 19 out of 21 regions in Sweden, for cleaning DFU. The DFU will be cleaned with PHMB twice a week. The treatment will be performed in accordance with instructions for Prontosan, PHMB.
Authors
Agnes Wold
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region