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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04405050
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a diabetes mellitus
* Men/women ≥21 years old
* Post-operative foot or ankle wounds sized \< 15cm
* ABI ≥0.5 or toe pressures \>30 mmHg
* Wounds indicated for treatment with NPWT
Exclusion Criteria:
* Active Charcot arthropathy
* Unable to use NPWT at home
* Untreated bone or soft tissue infection
* Is pregnant or plans to become pregnant
* Is nursing or actively lactating
* Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
* Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials. Active alcohol (\> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroin, or methamphetamines or if drug or alcohol use will interfere with follow-up visits in foot clinic in the opinion of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04405050
Study Brief:
Protocol Section:
NCT04405050