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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT01493895
Eligibility Criteria:
Inclusion Criteria:
1. Known Diabetes mellitus
2. With an active chronic wound in the foot, that has been treated conventionally for over 3 months.
3. No known osteomyelitis.
4. Size of wound: 1-8 cm2.
5. Ages: 21 - 75
6. Gender: male and female
Exclusion Criteria:
1. Signs of osteomyelitis.
2. The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.
3. There is active osteomyelitis in the bone underlying the ulcer.
4. Pregnant women.
5. Children under 21.
6. Presence of or known cancerous comorbidity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT01493895
Study Brief:
Protocol Section:
NCT01493895