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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT00288392
Eligibility Criteria:
Inclusion Criteria:
* Type 1 or Type 2 diabetes mellitus
* Age\>= 18 years
* Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones
* Study wound located on the foot or lower leg
* Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
* Adequate circulation to the foot, evidenced by a palpable pulse on the study foot
* Study wound \> 1.0cm2 but \< 20.0cm2
* Written informed consent
Exclusion Criteria:
* Pregnancy, lactation or absence of adequate contraception for fertile women
* Ankle/Brachial Index \< 0.7
* Severe malnutrition
* Clinical evidence of gangrene on any part of the foot with the study wound
* Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge on day 0
* One or more medical condition(s) that in the opinion of the investigator would make the patient an inappropriate candidate for the study
* Active osteomyelitis of the foot with the study wound
* Necrotic toes on the foot with the study wound
* Surgical procedure (other than debridement) on the foot with the study wound the last 21 days prior to screening
* Study wound over a Charcot's joint
* Evidence of deep tissue infection of the study wound at day 0
* Non-study wound on the study foot that is located within 5.0cm from the study wound at day 0
* Random blood sugar reading \> 450 mg/dL
* Alcohol or drug abuse
* Participation in other clinical studies in the last 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00288392
Study Brief:
Protocol Section:
NCT00288392