Diabetic Foot UlcerCHITOCHRONICNCT05570877
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
A study testing ChitoCare medical Wound Healing Gel in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Primex ehf at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- What is being tested?
- ChitoCare medical Wound Healing Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 11 Jan 2022to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Slovenia6 sites
General Hospital Celje
Celje, 3000
Health Centre Koper
Koper, 6000
University Clinical Center Maribor
Maribor, 2000
Medicina Mataln
Poljcane, Municipality of Poljčane, 2319
Nursing Home Šmarje pri Jelšah
Smarje pri Jelsah, 3240
Ordinacija Andrej Kravos
Žalec, Municipality of Žalec, 3310
Croatia3 sites
Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital
Zagreb, City of Zagreb, 1000
Clinical Hospital Sveti Duh
Zagreb, 1000
Marija Poliklinika
Zagreb, 1000
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Being tested
- ChitoCare medical Wound Healing Gel
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitoCare medical Wound Healing GelDevice
ChitoCare medical Wound Healing Gel is a CE-marked medical device.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Active group will apply ChitoCare medical Wound Healing Gel to the wound in addition to standard of care. Receives: Device: ChitoCare medical Wound Healing Gel |
| Control group | No intervention | Control group will only administer standard of care to treat their wounds. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing
Hazard ratio for time to complete healing (active group vs. control group).
Measured: up to 18 months
Secondary outcomes (6)
Complete healing rate
Proportion of completely healed ulcers (active group vs control group).
Measured: 4 weeks, 12 weeks
Reduction of wound size
Relative reduction of wound surface area compared to baseline (active group vs control group).
Measured: 4 weeks, 12 weeks
Time to 75% and 50% healing
Hazard ratio for time to 75% and 50% healing
Measured: up to 18 months
75% and 50% healing rate
Proportion of 75% and 50% area healed ulcers (active group vs. control group)
Measured: 4 weeks, 12 weeks
Secondary infections
Occurrence of secondary infections
Measured: up to 18 months
Incidence of adverse events (Safety of use)
Incidence of adverse events
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start11 Jan 2022
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primex ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vizera d.o.o., University of Ljubljana
- Responsible party
- Sponsor
- Investigators
- Helene Liette Lauzon, Study director, Primex ehf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570877
- Sponsor's protocol ID
- CHITOC-01
- Acronym
- CHITOCHRONIC
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05570877
- Acronym / sponsor ID
- CHITOCHRONIC / CHITOC-01
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Primex ehfIndustry (pharma, biotech, devices)
- Collaborators
- Vizera d.o.o., University of Ljubljana
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Device: ChitoCare medical Wound Healing GelActive group will apply ChitoCare medical Wound Healing Gel to the wound in addition to standard of care. |
| Control group | No intervention | –Control group will only administer standard of care to treat their wounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChitoCare medical Wound Healing GelChitoCare medical Wound Healing Gel is a CE-marked medical device. | Device | Active group |
Primary outcome
Time to complete healing
Time frame: up to 18 months
Hazard ratio for time to complete healing (active group vs. control group).
6 secondary outcomes
Complete healing rate
Time frame: 4 weeks, 12 weeks
Reduction of wound size
Time frame: 4 weeks, 12 weeks
Time to 75% and 50% healing
Time frame: up to 18 months
75% and 50% healing rate
Time frame: 4 weeks, 12 weeks
Secondary infections
Time frame: up to 18 months
Incidence of adverse events (Safety of use)
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Liette Lauzon study director
Primex ehf
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChitoCare medical Wound Healing Gel in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Primex ehf at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Slovenia, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete healing (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.