Diabetic Foot Ulcer
Conditions
Brief summary
The primary endpoint variable is difference in the time from baseline (randomization) to healing for patients randomized to treatment with HOCl and PHMB evaluated over 24 weeks of treatment measured as hazard ratio.
Detailed description
Proportion healed DFUs in HOCl group versus PHMB group at week 12., The difference in the change of the surface area of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) over 24 weeks., The difference in the change of the depth of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) to week 24., Difference in the mean number of days of antibiotic treatment for patients treated with HOCl versus PHMB from baseline (randomization) to week 24., Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.
Interventions
DRUGSODIUM HYPOCHLORITE
Sponsors
Vaestra Goetalandsregionen, University Of Gothenburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint variable is difference in the time from baseline (randomization) to healing for patients randomized to treatment with HOCl and PHMB evaluated over 24 weeks of treatment measured as hazard ratio. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion healed DFUs in HOCl group versus PHMB group at week 12., The difference in the change of the surface area of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) over 24 weeks., The difference in the change of the depth of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) to week 24., Difference in the mean number of days of antibiotic treatment for patients treated with HOCl versus PHMB from baseline (randomization) to week 24., Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HOCl versus PHMB from baseline (randomization) to week 24. | — |
Countries
Sweden
Outcome results
None listed