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:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT02319720
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects 18 years of age or older with chronic wounds
2. Wound present for at least one year
3. Subjects must understand and give written informed consent.
4. Subjects must agree to have biopsies performed as per protocol
5. Subjects must be accessible for weekly wound treatment and assessment visits
6. Patients with chronic osteomyelitis will be eligible. They must however be afebrile, and have completed a 6-week course of intravenous and/or oral antibiotics. The use of chronic suppressive antibiotics will be allowed.
Exclusion Criteria:
1. Have evidence of active infection at the wound site
2. Evidence of active malignancy in ulcer
3. Have any requirement for the use of systemic steroids or immunosuppressive agents
4. Be a pregnant female or nursing mother
5. Subjects who are known or found to be HIV positive
6. Evidence of dry/wet gangrene
7. History of alcohol or substance abuse within the past 18 months
8. Patients with severe medical conditions
1. Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years
2. Life expectancy less than two years
3. Severe cardiopulmonary disease restricting ambulation to the clinical facility
9. Severe arterial or vascular disease requiring or best treated by amputation
10. Untreated osteomyelitis affecting the ulcer area or osteomyelitis affecting the ulcer area not receiving aggressive treatment
11. History of poor compliance, unreliability
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02319720
Study Brief:
Protocol Section:
NCT02319720