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ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds (CHITOCHRONIC)

Primary Purpose

Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

Slovenia

Study Type

Interventional

Intervention

ChitoCare medical Wound Healing Gel

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
- Size of the wound ≥ 0.5 cm2
- Wound is not infected at the time of randomization
- Wound is present for at least 4 weeks
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)
Medical condition likely to require systemic corticosteroids during the study period
Pregnant and lactating women

Sites / Locations

General Hospital CeljeRecruiting
Health Centre KoperRecruiting
University Clinical Center MariborRecruiting
Nursing Home Šmarje pri JelšahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active group

Control group

Arm Description

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

Control group will only administer standard of care to treat their wounds.

Outcomes

Primary Outcome Measures

Time to complete healing

Hazard ratio for time to complete healing (active group vs. control group).

Secondary Outcome Measures

Complete healing rate

Proportion of completely healed ulcers (active group vs control group).

Reduction of wound size

Relative reduction of wound surface area compared to baseline (active group vs control group).

Time to 75% and 50% healing

Hazard ratio for time to 75% and 50% healing

75% and 50% healing rate

Proportion of 75% and 50% area healed ulcers (active group vs. control group)

Secondary infections

Occurrence of secondary infections

Safety of use

Incidence of adverse events

Full Information

NCT ID

NCT05570877

First Posted

October 4, 2022

Last Updated

October 4, 2022

Sponsor

Primex ehf

Collaborators

Vizera d.o.o., University of Ljubljana, Faculty of Pharmacy

1. Study Identification

Unique Protocol Identification Number

NCT05570877

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2022 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Primex ehf

Collaborators

Vizera d.o.o., University of Ljubljana, Faculty of Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Control group will only administer standard of care to treat their wounds.

Intervention Type

Device

Intervention Name(s)

ChitoCare medical Wound Healing Gel

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to complete healing

Description

Hazard ratio for time to complete healing (active group vs. control group).

Time Frame

up to 18 months

Secondary Outcome Measure Information:

Title

Complete healing rate

Description

Proportion of completely healed ulcers (active group vs control group).

Time Frame

4 weeks, 12 weeks

Title

Reduction of wound size

Description

Relative reduction of wound surface area compared to baseline (active group vs control group).

Time Frame

4 weeks, 12 weeks

Title

Time to 75% and 50% healing

Description

Hazard ratio for time to 75% and 50% healing

Time Frame

up to 18 months

Title

75% and 50% healing rate

Description

Proportion of 75% and 50% area healed ulcers (active group vs. control group)

Time Frame

4 weeks, 12 weeks

Title

Secondary infections

Description

Occurrence of secondary infections

Time Frame

up to 18 months

Title

Safety of use

Description

Incidence of adverse events

Time Frame

up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Size of the wound ≥ 0.5 cm2 Wound is not infected at the time of randomization Wound is present for at least 4 weeks 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) Medical condition likely to require systemic corticosteroids during the study period Pregnant and lactating women

Facility Information:

Facility Name

General Hospital Celje

City

Celje

ZIP/Postal Code

3000

Country

Slovenia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maja Navodnik Preložnik, MD

Phone

3 423 3835

Ext

+386

maja.navodnik-preloznik@sb-celje.si

First Name & Middle Initial & Last Name & Degree

Maja Navodnik Preložnik, MD

First Name & Middle Initial & Last Name & Degree

Lučka Leskovšek, MD

Facility Name

Health Centre Koper

City

Koper

ZIP/Postal Code

6000

Country

Slovenia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jana Komel, MD

Phone

5 664 72 17

Ext

+386

jana.komel@gmail.com

First Name & Middle Initial & Last Name & Degree

Jana Komel, MD

Facility Name

University Clinical Center Maribor

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vesna Breznik, MD

Phone

2 321 27 05

Ext

+386

vesna.breznik@ukc-mb.si

First Name & Middle Initial & Last Name & Degree

Vesna Breznik, MD

First Name & Middle Initial & Last Name & Degree

Irena Peteln, MD

First Name & Middle Initial & Last Name & Degree

Martina Lipič, MD

Facility Name

Nursing Home Šmarje pri Jelšah

City

Šmarje pri Jelšah

ZIP/Postal Code

3240

Country

Slovenia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marko Starbek, MD

Phone

7 292 72 10

Ext

+386

info@medicina-mataln.si

First Name & Middle Initial & Last Name & Degree

Mitja Mataln, MD

12. IPD Sharing Statement

Learn more about this trial

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

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