Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer
Conditions
Brief 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.
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.
Interventions
DEVICEChitoCare medical Wound Healing Gel
ChitoCare medical Wound Healing Gel is a CE-marked medical device.
Sponsors
Vizera d.o.o.
University of Ljubljana
Primex ehf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete healing | up to 18 months | Hazard ratio for time to complete healing (active group vs. control group). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of wound size | 4 weeks, 12 weeks | Relative reduction of wound surface area compared to baseline (active group vs control group). |
| Time to 75% and 50% healing | up to 18 months | Hazard ratio for time to 75% and 50% healing |
| Complete healing rate | 4 weeks, 12 weeks | Proportion of completely healed ulcers (active group vs control group). |
| Secondary infections | up to 18 months | Occurrence of secondary infections |
| Incidence of adverse events (Safety of use) | up to 18 months | Incidence of adverse events |
| 75% and 50% healing rate | 4 weeks, 12 weeks | Proportion of 75% and 50% area healed ulcers (active group vs. control group) |
Countries
Croatia, Slovenia
Outcome results
None listed