ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds

Launched by PRIMEX EHF · Oct 4, 2022

Keywords

ClinConnect Summary

The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolle...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent must be given
• • 2. Patient ≥ 18 years old
• 3. Presence of chronic wound (Wagner grade I and II diabetic foot ulcer, venous leg ulcer or pressure ulcer) that meets the following criteria:
• • Size of the wound ≥ 0.5 cm2
• • Wound is not infected at the time of randomization
• • Wound is present for at least 4 weeks
• • 4. Able to understand and comply with the requirements of the study
• Exclusion Criteria:
• • 1. Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb\<100 g/L), neoplasia)
• • 2. Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
• • 3. Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the investigator
• • 4. Patients diagnosed with autoimmune connective tissue diseases
• • 5. Previous treatment under this clinical protocol
• • 6. Participation in another clinical trial
• • 7. 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
• • 8. Allergy to shellfish (for active study group)
• • 9. Medical condition likely to require systemic corticosteroids during the study period
• • 10. Pregnant and lactating women