Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2025-12-25 @ 1:30 AM
NCT ID:
NCT03865394
Eligibility Criteria:
Inclusion Criteria:
1. Signing informed consent form.
2. Above the age of 18
3. Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
4. Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
5. Blood level of glycated haemoglobin (HbA1c) \<=11%
6. Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (\>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\>=50 mmHg) of the affected limb.
7. General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures.
Exclusion Criteria:
1. Lack of patient's cooperation
2. Wound etiology other than diabetic foot syndrome
3. Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (\<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\<50 mmHg)
4. Active wound infection, which would require the treatment with antibiotics
5. Known allergy to ingredients of study product (thrombin, penicillin).
6. Active venous thromboembolism
7. Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study
8. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03865394
Study Brief:
Protocol Section:
NCT03865394