Clinical trial NCT04178525: Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
Official title: A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Chronic wounds
Diabetic foot ulcer
Chitosan gel
Lead sponsor: Primex ehf
Sponsor class: INDUSTRY
Collaborators: name: Vizera d.o.o.
name: University of Ljubljana
First posted: 2019-11-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be applied at a 1:1 ratio on study level, and at each individual site. Sixty (60) patients will be included in the study, 30 in each arm.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be given
* Patient ≥ 18 years old
* Diagnosed with type I or type II diabetes mellitus
* Glycosylated haemoglobin, HbA1c, ≤ 12%
* Presence of diabetic foot ulcer or an amputation wound that meets following criteria:

  1. Size of the wound 0,5 - 12 cm\^2
  2. Wagner grade I or II
  3. Wound is not infected
  4. Wound present for at least 4 weeks
* If multiple wounds are present, the biggest wound fitting the criteria is selected and the distance from other wounds must be at least 2 cm
* If there is an amputation wound present, it can be used for the purpose of this study if it fits the rest of the criteria
* Adequate perfusion (good, strong foot pulses). If foot pulses are weak, evaluation of perfusion pressures with Doppler ultrasound is performed.
* Able to understand and comply with the requirements of the trial

Exclusion Criteria:

* Known history of alcohol or drug abuse
* Use of any antibiotic medication within the last 7 days prior to the first application of study product
* Patients presenting with Wagner Grade III or higher ulcer
* Patients with serious concomitant disease (cancer, heart failure ( NYHA class IV), severe anemia (Hb\<100 g/L), neoplasia)
* Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
* Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the doctor
* Excessive lymphedema that could interfere with wound healing (if there is mild edema treated with compression therapy the patient can be included)
* Patients diagnosed with autoimmune connective tissues diseases
* Previous treatment under this clinical protocol
* Participation in another clinical trial up to 30 days before the randomization visit.
* Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
* Medical condition likely to require systemic corticosteroids during the study period
* Allergic to shellfish, chitosan or one of ChitoCare product compounds
* Immobile patients
* Pregnant and lactating women
* Significant increase in wound healing during run-in period (reduction of wound size area ≥ 40%)
* BMI \> 39 kg/m2

Primary outcomes:
measure: Difference in proportions of ulcers completely healed for experimental group compared to control group.
timeFrame: 10 weeks
Secondary outcomes:
measure: Difference in proportion of ulcers completely healed for experimental group compared to the control group
timeFrame: 2, 4, 6 and 8 weeks
measure: Difference in reduction of diabetic ulcer wound size for experimental group compared to control group.
timeFrame: 2, 4, 6, 8, 10 and 14 weeks
measure: Difference in time to complete healing for experimental group compared to control group.
timeFrame: Baseline to 14 weeks (whole study duration)
measure: Difference in improved quality of life for experimental group compared to control group.
timeFrame: 4 weeks and 10 weeks
measure: Difference in improved state of the wound for experimental group compared to control group using Bates-Jensen wound assessment tool (BWAT).
timeFrame: 2, 4, 6, 8, 10 and 14 weeks
measure: Difference in improved state of the wound for experimental group compared to control group according to Wagner Ulcer Classification.
timeFrame: 2, 4, 6, 8, 10 and 14 weeks
measure: Secondary infections that may occur during the study for experimental group compared to control group.
timeFrame: Baseline to 14 weeks (whole study duration)
measure: Incidence of treatment related adverse events for experimental group compared to control group.
timeFrame: Baseline to 14 weeks (whole study duration)
measure: To track diabetic ulcer recurrence for experimental group compared to control group in patients whose wound completely healed.
timeFrame: Baseline to 14 weeks (whole study duration)
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Clinic Vuk Vrhovac
city: Celje
country: Slovenia
facility: General Hospital Celje
city: Kranj
country: Slovenia
facility: Clinic Golnik - Diabetic Clinic Kranj
city: Ljubljana
country: Slovenia
facility: University Hospital Center Ljubljana
city: Murska Sobota
country: Slovenia
facility: General Hospital Murska Sobota
Study officials:
affiliation: General Hospital Celje, Slovenia
name: Maja Navodnik Preložnik, MD
role: PRINCIPAL_INVESTIGATOR
References: