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:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT04275804
Eligibility Criteria:
Inclusion criteria:
* \>18 years old (legally able to self-sign consent)
* Able to stand independently
* Biochemically confirmed Diabetes with a fasting plasma glucose ≥ 7.0 mmol/L, or a random plasma glucose ≥ 11.1 mmol/L or hemoglobin A1c (HbA1c) level ≥ 6.5%
* Ulcers will be below the level of the malleoli, excluding those confined to the interdigital web space
* Cross-sectional area of the index ulcer should be 50- 1000 mm2
* Wagner stage 2-3
* Not active infection according to the Infectious Diseases Society of America guidelines
Exclusion criteria:
* Severe cognitive impairment or severe comorbidity, which may impair ability to adhere to intervention plan, e.g. severe dementia, poor cardiopulmonary reserve requiring home oxygen, daily hemodialysis etc.
* Evidence of active infection
* Recent revascularization procedure (\<12 weeks)
* Recently received medication/intervention which might affect cell proliferation (eg chemotherapy, radiotherapy etc)
* Allergy to dressing, adhesives or antibiotics
* Incapable to understand the study protocol or provide written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04275804
Study Brief:
Protocol Section:
NCT04275804