Diabetic Foot UlcerCHITOWOUNDNCT04178525
Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
A study testing ChitoCare gel in people with Diabetic Foot Ulcer, run by Primex ehf at 5 sites in 2 countries.
Trial summary
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- ChitoCare gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Aug 2018to 22 Sep 2020
- 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
- Diagnosed with type I or type II diabetes mellitus
- Glycosylated haemoglobin, HbA1c, ≤ 12%
- Presence of diabetic foot ulcer or an amputation wound that meets following criteria:
- Size of the wound 0,5 - 12 cm^2
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- Wagner grade I or II
- Wound is not infected
- Wound present for at least 4 weeks
- If multiple wounds are present, the biggest wound fitting the criteria is selected and the distance from other wounds must be at least 2 cm
- If there is an amputation wound present, it can be used for the purpose of this study if it fits the rest of the criteria
- Adequate perfusion (good, strong foot pulses). If foot pulses are weak, evaluation of perfusion pressures with Doppler ultrasound is performed.
- Able to understand and comply with the requirements of the trial
Who cannot join
- Known history of alcohol or drug abuse
- Use of any antibiotic medication within the last 7 days prior to the first application of study product
- Patients presenting with Wagner Grade III or higher ulcer
- Patients with serious concomitant disease (cancer, heart failure ( NYHA class IV), severe anemia (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 doctor
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- Excessive lymphedema that could interfere with wound healing (if there is mild edema treated with compression therapy the patient can be included)
- Patients diagnosed with autoimmune connective tissues diseases
- Previous treatment under this clinical protocol
- Participation in another clinical trial up to 30 days before the randomization visit.
- 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
- Medical condition likely to require systemic corticosteroids during the study period
- Allergic to shellfish, chitosan or one of ChitoCare product compounds
- Immobile patients
- Pregnant and lactating women
- Significant increase in wound healing during run-in period (reduction of wound size area ≥ 40%)
- BMI > 39 kg/m2
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Slovenia4 sites
General Hospital Celje
Celje, 3000
Clinic Golnik - Diabetic Clinic Kranj
Kranj, 4000
University Hospital Center Ljubljana
Ljubljana, 1000
General Hospital Murska Sobota
Murska Sobota, 9000
About this study
Official title: A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- ChitoCare gel, Placebo gel
- Keywords
- Chronic wounds, Diabetic foot ulcer, Chitosan gel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitoCare gelDevice
ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks.
Placebo gelDevice
Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Experimental group | Experimental | ChitoCare gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change) Receives: Device: ChitoCare gel |
| Arm B (Control group) | Placebo comparator | Placebo gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change) Receives: Device: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportions of ulcers completely healed for experimental group compared to control group.
Relative healing rate (ratio between the proportion of ulcers healed for experimental group to proportion of ulcers healed in control group (= healing rate)).
Measured: 10 weeks
Secondary outcomes (9)
Difference in proportion of ulcers completely healed for experimental group compared to the control group
Relative healing rate (ratio between the proportion of ulcers healed for experimental group to the proportion of ulcers healed in control group)
Measured: 2, 4, 6 and 8 weeks
Difference in reduction of diabetic ulcer wound size for experimental group compared to control group.
Relative reduction of wound surface area.
Measured: 2, 4, 6, 8, 10 and 14 weeks
Difference in time to complete healing for experimental group compared to control group.
Hazard ratio for time to complete healing (experimental group vs. control group)
Measured: Baseline to 14 weeks (whole study duration)
Difference in improved quality of life for experimental group compared to control group.
The relative improvement of quality of life from the baseline value using the 36-Item Short Form Survey (SF-36) questionnaire (RAND Corporation).
Measured: 4 weeks and 10 weeks
Difference in improved state of the wound for experimental group compared to control group using Bates-Jensen wound assessment tool (BWAT).
The relative improvement of the state of the wound using Bates-Jensen wound assessment tool (BWAT).
Measured: 2, 4, 6, 8, 10 and 14 weeks
Difference in improved state of the wound for experimental group compared to control group according to Wagner Ulcer Classification.
The relative improvement of the state of the wound using Wagner Ulcer Classification.
Measured: 2, 4, 6, 8, 10 and 14 weeks
Secondary infections that may occur during the study for experimental group compared to control group.
Occurrence of secondary infection.
Measured: Baseline to 14 weeks (whole study duration)
Incidence of treatment related adverse events for experimental group compared to control group.
The incidence of treatment related adverse events.
Measured: Baseline to 14 weeks (whole study duration)
To track diabetic ulcer recurrence for experimental group compared to control group in patients whose wound completely healed.
The incidence of diabetic ulcer recurrence.
Measured: Baseline to 14 weeks (whole study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start2 Aug 2018
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Why it stopped: COVID-19 restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Randomization will be applied at a 1:1 ratio on study level, and at each individual site. Sixty (60) patients will be included in the study, 30 in each arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 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
- Maja Navodnik Preložnik, MD, Principal investigator, General Hospital Celje, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178525
- Sponsor's protocol ID
- CHITO-01
- Acronym
- CHITOWOUND
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slivnik M, Navodnik Preloznik M, Fir M, Jazbar J, Cebron Lipovec N, Locatelli I, Liette Lauzon H, Urbancic Rovan V. A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study). BMJ Open Diabetes Res Care. 2024 Jun 23;12(3):e004195. doi: 10.1136/bmjdrc-2024-004195.
PubMed 38909998
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
- ClinicalTrials.gov ID
- NCT04178525
- Acronym / sponsor ID
- CHITOWOUND / CHITO-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Chronic wounds, Diabetic foot ulcer, Chitosan gel
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 restrictions
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Primex ehfIndustry (pharma, biotech, devices)
- Collaborators
- Vizera d.o.o., University of Ljubljana
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 26 Nov 2019 (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.
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization will be applied at a 1:1 ratio on study level, and at each individual site. Sixty (60) patients will be included in the study, 30 in each arm.
| Arm | Type | Receives |
|---|---|---|
| Arm A (Experimental group | Experimental | Device: ChitoCare gelChitoCare gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change) |
| Arm B (Control group) | Placebo comparator | Device: Placebo gelPlacebo gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent must be given
- Patient ≥ 18 years old
- Diagnosed with type I or type II diabetes mellitus
- Glycosylated haemoglobin, HbA1c, ≤ 12%
- Presence of diabetic foot ulcer or an amputation wound that meets following criteria:
Key exclusion criteria (17 listed)
- Known history of alcohol or drug abuse
- Use of any antibiotic medication within the last 7 days prior to the first application of study product
- Patients presenting with Wagner Grade III or higher ulcer
- Patients with serious concomitant disease (cancer, heart failure ( NYHA class IV), severe anemia (Hb<100 g/L), neoplasia)
- Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
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 gelChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks. | Device | Arm A (Experimental group |
| Placebo gelPlacebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks. | Device | Arm B (Control group) |
Primary outcome
Difference in proportions of ulcers completely healed for experimental group compared to control group.
Time frame: 10 weeks
Relative healing rate (ratio between the proportion of ulcers healed for experimental group to proportion of ulcers healed in control group (= healing rate)).
9 secondary outcomes
Difference in proportion of ulcers completely healed for experimental group compared to the control group
Time frame: 2, 4, 6 and 8 weeks
Difference in reduction of diabetic ulcer wound size for experimental group compared to control group.
Time frame: 2, 4, 6, 8, 10 and 14 weeks
Difference in time to complete healing for experimental group compared to control group.
Time frame: Baseline to 14 weeks (whole study duration)
Difference in improved quality of life for experimental group compared to control group.
Time frame: 4 weeks and 10 weeks
Difference in improved state of the wound for experimental group compared to control group using Bates-Jensen wound assessment tool (BWAT).
Time frame: 2, 4, 6, 8, 10 and 14 weeks
Difference in improved state of the wound for experimental group compared to control group according to Wagner Ulcer Classification.
Time frame: 2, 4, 6, 8, 10 and 14 weeks
Secondary infections that may occur during the study for experimental group compared to control group.
Time frame: Baseline to 14 weeks (whole study duration)
Incidence of treatment related adverse events for experimental group compared to control group.
Time frame: Baseline to 14 weeks (whole study duration)
To track diabetic ulcer recurrence for experimental group compared to control group in patients whose wound completely healed.
Time frame: Baseline to 14 weeks (whole study duration)
Results and safety
The study was stopped early (reason given: COVID-19 restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 38909998Slivnik M, Navodnik Preloznik M, Fir M, Jazbar J, Cebron Lipovec N, Locatelli I, Liette Lauzon H, Urbancic Rovan V. A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study). BMJ Open Diabetes Res Care. 2024 Jun 23;12(3):e004195. doi: 10.1136/bmjdrc-2024-004195.
- Individual participant dataSharing planned: No
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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.
Maja Navodnik Preložnik, MD principal investigator
General Hospital Celje, Slovenia
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChitoCare gel in people with Diabetic Foot Ulcer, run by Primex ehf at 5 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 13 inclusion and 17 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: stopped early, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: COVID-19 restrictions). Results are not available in the source record.
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?
Difference in proportions of ulcers completely healed for experimental group compared to control group. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178525, which also lists 1 linked publication.
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 13 Nov 2020.