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Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds (CHITOWOUND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178525
Recruitment Status : Terminated (COVID-19 restrictions)
First Posted : November 26, 2019
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Vizera d.o.o.
University of Ljubljana
Information provided by (Responsible Party):
Primex ehf

Brief 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 effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: ChitoCare gel Device: Placebo gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: The patients, investigators and other personnel involved in the study will be blinded with respect to the study treatment of the patient, until the end of the study.
Primary Purpose: Treatment
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
Actual Study Start Date : August 2, 2018
Actual Primary Completion Date : September 22, 2020
Actual Study Completion Date : September 22, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Poliglusam

Arm Intervention/treatment
Experimental: Arm A (Experimental group
ChitoCare gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change)
Device: ChitoCare gel
ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks.

Placebo Comparator: Arm B (Control group)
Placebo gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change)
Device: Placebo gel
Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks.




Primary Outcome Measures :
  1. 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)).


Secondary Outcome Measures :
  1. Difference in proportion of ulcers completely healed for experimental group compared to the control group [ Time Frame: 2, 4, 6 and 8 weeks ]
    Relative healing rate (ratio between the proportion of ulcers healed for experimental group to the proportion of ulcers healed in control group)

  2. 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 ]
    Relative reduction of wound surface area.

  3. Difference in time to complete healing for experimental group compared to control group. [ Time Frame: Baseline to 14 weeks (whole study duration) ]
    Hazard ratio for time to complete healing (experimental group vs. control group)

  4. Difference in improved quality of life for experimental group compared to control group. [ Time Frame: 4 weeks and 10 weeks ]
    The relative improvement of quality of life from the baseline value using the 36-Item Short Form Survey (SF-36) questionnaire (RAND Corporation).

  5. 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 ]
    The relative improvement of the state of the wound using Bates-Jensen wound assessment tool (BWAT).

  6. 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 ]
    The relative improvement of the state of the wound using Wagner Ulcer Classification.

  7. Secondary infections that may occur during the study for experimental group compared to control group. [ Time Frame: Baseline to 14 weeks (whole study duration) ]
    Occurrence of secondary infection.

  8. Incidence of treatment related adverse events for experimental group compared to control group. [ Time Frame: Baseline to 14 weeks (whole study duration) ]
    The incidence of treatment related adverse events.

  9. 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) ]
    The incidence of diabetic ulcer recurrence.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Size of the wound 0,5 - 12 cm^2
    2. Wagner grade I or II
    3. Wound is not infected
    4. 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178525


Locations
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Croatia
University Clinic Vuk Vrhovac
Zagreb, Croatia, 10000
Slovenia
General Hospital Celje
Celje, Slovenia, 3000
Clinic Golnik - Diabetic Clinic Kranj
Kranj, Slovenia, 4000
University Hospital Center Ljubljana
Ljubljana, Slovenia, 1000
General Hospital Murska Sobota
Murska Sobota, Slovenia, 9000
Sponsors and Collaborators
Primex ehf
Vizera d.o.o.
University of Ljubljana
Investigators
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Principal Investigator: Maja Navodnik Preložnik, MD General Hospital Celje, Slovenia
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Responsible Party: Primex ehf
ClinicalTrials.gov Identifier: NCT04178525    
Other Study ID Numbers: CHITO-01
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Primex ehf:
Chronic wounds
Diabetic foot ulcer
Chitosan gel
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases