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

Last updated: February 17, 2025
Sponsor: Primex ehf
Overall Status: Completed

Phase

N/A

Condition

Pressure Ulcer

Diabetes Mellitus, Type 2

Diabetes Mellitus Types I And Ii

Treatment

ChitoCare medical Wound Healing Gel

Clinical Study ID

NCT05570877
CHITOC-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 legulcer 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

  1. Able to understand and comply with the requirements of the study

Exclusion

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 onthe 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 ofthe investigator, was known to interfere with, or affect the rate and quality ofwound 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

Study Design

Total Participants: 92
Treatment Group(s): 1
Primary Treatment: ChitoCare medical Wound Healing Gel
Phase:
Study Start date:
January 11, 2022
Estimated Completion Date:
October 15, 2024

Study Description

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 enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.

Connect with a study center

  • Clinical Hospital Sveti Duh

    Zagreb, 1000
    Croatia

    Site Not Available

  • Marija Poliklinika

    Zagreb, 1000
    Croatia

    Site Not Available

  • Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital

    Zagreb, 1000
    Croatia

    Site Not Available

  • General Hospital Celje

    Celje, 3000
    Slovenia

    Site Not Available

  • Health Centre Koper

    Koper, 6000
    Slovenia

    Site Not Available

  • University Clinical Center Maribor

    Maribor, 2000
    Slovenia

    Site Not Available

  • Medicina Mataln

    Poljčane, 2319
    Slovenia

    Site Not Available

  • Nursing Home Šmarje pri Jelšah

    Šmarje pri Jelšah, 3240
    Slovenia

    Site Not Available

  • Ordinacija Andrej Kravos

    Žalec, 3310
    Slovenia

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.