Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers

Completed · Phase 4

Conditions studied: Diabetic Foot, Varicose Ulcer, Pressure Ulcer

In brief

The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers. It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the VERSAJET™ device than with conventional surgical procedures.

Key facts

Study ID

NCT00521027

Run by

Smith & Nephew, Inc.

People needed

46

Starts

2006-04-01

Expected to finish

2006-09-01

Last updated by the study team

2018-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clara Maass Medical Center — Belleville, New Jersey, United States

Full record on ClinicalTrials.gov

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