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 @ 5:10 AM
Ignite Modification Date:
2025-12-25 @ 5:10 AM
NCT ID:
NCT00521027
Eligibility Criteria:
Inclusion Criteria:
* Patients who are at least 18 years of age.
* Males and females (provided they are not pregnant or, if of reproductive age, are using contraception).
* Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot.
* Patients undergoing surgical debridement of their reference ulcer in the operating room (OR).
* Patients undergoing their first surgical debridement of the reference ulcer.
* Patients suitable for debridement of their reference ulcer with both VERSAJET™ and conventional debridement techniques.
* Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation.
Exclusion Criteria:
* Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour).
* Patients with haemophilia
* Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study.
* Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV).
* Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing.
* Patients with a known history of poor compliance with medical treatment.
* Patients who have participated in this evaluation previously or are currently participating in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00521027
Study Brief:
Protocol Section:
NCT00521027