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

Not Applicable

Completed

• Conditions: Pressure Ulcer; Diabetic Foot Ulcer; Venous Leg Ulcer
• Interventions: Device: ChitoCare medical Wound Healing Gel

• Registration Number: NCT05570877
• Lead Sponsor: Primex ehf

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-11
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	ChitoCare medical Wound Healing Gel	Active group will apply ChitoCare medical Wound Healing Gel to the wound in addition to standard of care.

Primary Outcome Measures

Name	Time	Method
Time to complete healing	up to 18 months	Hazard ratio for time to complete healing (active group vs. control group).

Secondary Outcome Measures

Name	Time	Method
Complete healing rate	4 weeks, 12 weeks	Proportion of completely healed ulcers (active group vs control group).
Reduction of wound size	4 weeks, 12 weeks	Relative reduction of wound surface area compared to baseline (active group vs control group).
Time to 75% and 50% healing	up to 18 months	Hazard ratio for time to 75% and 50% healing
75% and 50% healing rate	4 weeks, 12 weeks	Proportion of 75% and 50% area healed ulcers (active group vs. control group)
Secondary infections	up to 18 months	Occurrence of secondary infections
Incidence of adverse events (Safety of use)	up to 18 months	Incidence of adverse events

Trial Locations

Locations (9)

Clinical Hospital Sveti Duh; 🇭🇷 Zagreb, Croatia

Marija Poliklinika; 🇭🇷 Zagreb, Croatia

General Hospital Celje; 🇸🇮 Celje, Slovenia

Health Centre Koper; 🇸🇮 Koper, Slovenia

University Clinical Center Maribor; 🇸🇮 Maribor, Slovenia

Medicina Mataln; 🇸🇮 Poljčane, Slovenia

Nursing Home Šmarje pri Jelšah; 🇸🇮 Šmarje pri Jelšah, Slovenia

Ordinacija Andrej Kravos; 🇸🇮 Žalec, Slovenia

Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital; 🇭🇷 Zagreb, Croatia