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

Diabetic Foot Ulcer Clinical Trial

— CHITOCHRONIC  

Official title:

A Multi-Centre, Randomized, 2-arm, Open-labelled, Controlled PMCF Study to Evaluate the Safety and Performance of ChitoCare Medical Wound Healing Gel in Healing of Chronic Wounds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570877
• Other study ID #: CHITOC-01
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: Primex ehf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• ChitoCare medical Wound Healing Gel
ChitoCare medical Wound Healing Gel is a CE-marked medical device.

Locations

Country	Name	City	State
Slovenia	Nursing Home Šmarje pri Jelšah	Šmarje pri Jelšah
Slovenia	General Hospital Celje	Celje
Slovenia	Health Centre Koper	Koper
Slovenia	University Clinical Center Maribor	Maribor

Sponsors (3)

Lead Sponsor	Collaborator
Primex ehf	University of Ljubljana, Faculty of Pharmacy, Vizera d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

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