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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT01754506
Eligibility Criteria:
Inclusion Criteria:
* men and women
* ages 18-85 years
* having at least one existing CVLU between the ankle and knee for ≥ 3 months
* medical clearance to take 81mg/d of aspirin
* prescribed compression therapy; ambulatory
* ankle brachial pressure index (ABPI) of ≥ 0.8
* target wound of ≥ 1 x 1 inches (6.25 cm2)
* can understand English and sign own consent
Exclusion Criteria:
* allergy to fish or seafood
* exposed bone, tendon or fascia around target wound
* receiving warfarin or Plavix therapy
* immunologic related condition (e.g. Crohn's disease, systemic lupus erythematosus)
* chronic inflammatory skin diseases (e.g. pyoderma gangrenosum, psoriasis)
* requiring non-steroidal anti-inflammatory drugs \> 2x a week
* nutritional supplements or corticosteroids
* chronic renal insufficiency
* already in a study related to CVLU.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01754506
Study Brief:
Protocol Section:
NCT01754506