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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT01113658
Eligibility Criteria:
Inclusion Criteria:
* Wound \< 10 cm in greatest diameter
* Patient \>18 years of age
* Willing and able to sign informed consent
Exclusion Criteria:
* Patients with wound-related cellulitis
* Patients with thick eschar at wound base post debridement
* Patients with wounds located in an area not amenable to forming an air- tight seal
* Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome
* Patient has untreated osteomyelitis
* Patient is allergic to wound care products
* Patient wounds with exposed blood vessels not suitable for negative pressure therapy
* Pregnant or pregnancy-suspected patients
* Subject actively participating in other clinical trials that conflict with the current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01113658
Study Brief:
Protocol Section:
NCT01113658