Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds (CHITOWOUND)

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Chronic wounds, Diabetic foot ulcer, Chitosan gel Read More

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