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 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT04475861
Eligibility Criteria:
Inclusion Criteria:
1. are men or non-pregnant women, aged ≥ 40 years or ≤ 80 years
2. have a history of foot ulcers for more than 1 month
3. have a serum albumin level ≤ 4.0 or an ABI level ≤ 1
Exclusion Criteria:
1. Have active malignancy
2. Have acute gastrointestinal surgery
3. are receiving dialysis
4. have heart failure (NYHA Fc ≥ 3), liver cirrhosis (Child class \> B), or myocardial infarction in the past 3 months,
5. have wounds complicated with persistent osteomyelitis or Charcot deformity
6. are receiving hydroxyurea or steroid treatment
7. have alcohol abuse, any mental or physiological condition that may interfere with dietary intake, and those who are unable to follow orders or cooperate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04475861
Study Brief:
Protocol Section:
NCT04475861