CompletedNot Applicable

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

Croatia, Slovenia92 participantsStarted 2022-01-11

Plain-language summary

We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive effect on wound healing, and has antimicrobial properties.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent must be given
✓. Patient ≥ 18 years old
✓. Presence of chronic wound (Wagner grade I and II diabetic foot ulcer, venous leg ulcer or pressure ulcer) that meets the following criteria:
✓. Able to understand and comply with the requirements of the study

Exclusion criteria

✕. Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (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 investigator
✕. Patients diagnosed with autoimmune connective tissue diseases
✕. Previous treatment under this clinical protocol
✕. Participation in another clinical trial
✕. 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
✕. Allergy to shellfish (for active study group)

What they're measuring

Time to complete healing

Timeframe: up to 18 months

Trial details

NCT IDNCT05570877

SponsorPrimex ehf

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-15

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials