Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks.
Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks.
University Clinic Vuk Vrhovac
Zagreb, Croatia
General Hospital Celje
Celje, Slovenia
Clinic Golnik - Diabetic Clinic Kranj
Kranj, Slovenia
University Hospital Center Ljubljana
Ljubljana, Slovenia
Difference in proportions of ulcers completely healed for experimental group compared to control group.
Relative healing rate (ratio between the proportion of ulcers healed for experimental group to proportion of ulcers healed in control group (= healing rate)).
Time frame: 10 weeks
Difference in proportion of ulcers completely healed for experimental group compared to the control group
Relative healing rate (ratio between the proportion of ulcers healed for experimental group to the proportion of ulcers healed in control group)
Time frame: 2, 4, 6 and 8 weeks
Difference in reduction of diabetic ulcer wound size for experimental group compared to control group.
Relative reduction of wound surface area.
Time frame: 2, 4, 6, 8, 10 and 14 weeks
Difference in time to complete healing for experimental group compared to control group.
Hazard ratio for time to complete healing (experimental group vs. control group)
Time frame: Baseline to 14 weeks (whole study duration)
Difference in improved quality of life for experimental group compared to control group.
The relative improvement of quality of life from the baseline value using the 36-Item Short Form Survey (SF-36) questionnaire (RAND Corporation).
Time frame: 4 weeks and 10 weeks
Difference in improved state of the wound for experimental group compared to control group using Bates-Jensen wound assessment tool (BWAT).
The relative improvement of the state of the wound using Bates-Jensen wound assessment tool (BWAT).
Time frame: 2, 4, 6, 8, 10 and 14 weeks
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General Hospital Murska Sobota
Murska Sobota, Slovenia
Difference in improved state of the wound for experimental group compared to control group according to Wagner Ulcer Classification.
The relative improvement of the state of the wound using Wagner Ulcer Classification.
Time frame: 2, 4, 6, 8, 10 and 14 weeks
Secondary infections that may occur during the study for experimental group compared to control group.
Occurrence of secondary infection.
Time frame: Baseline to 14 weeks (whole study duration)
Incidence of treatment related adverse events for experimental group compared to control group.
The incidence of treatment related adverse events.
Time frame: Baseline to 14 weeks (whole study duration)
To track diabetic ulcer recurrence for experimental group compared to control group in patients whose wound completely healed.
The incidence of diabetic ulcer recurrence.
Time frame: Baseline to 14 weeks (whole study duration)