Diabetic FootPhase 4NCT00521027
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
A Phase 4 study testing Versajet Hydrosurgery System and Conventional surgical debridement techniques in people with Diabetic Foot and Varicose Ulcer, run by Smith & Nephew, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
- What is being tested?
- Versajet Hydrosurgery System and Conventional surgical debridement techniques
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clara Maass Medical Center
Belleville, New Jersey, 07109
About this study
Official title: A Prospective, Comparative, Single-centre Clinical Evaluation to Investigate the Skin-to-skin Time of the First Surgical Debridement of Lower Extremity Ulcers With VERSAJET™ Hydrosurgery System and Conventional Debridement Techniques.
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.
Read the detailed description
This is prospective, comparative clinical evaluation to investigate whether there is a reduction in the skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques. Skin-to-skin time is defined as the time of incision to the end time of debridement (wound ready for dressing application). Conventional debridement is defined as scalpel plus pulse lavage.
The purpose of this comparison is to demonstrate the resource savings which VERSAJET™ may provide in terms of operating room (OR) and personnel time, in addition to the potential to reduce the procedure, and possibly anaesthetic, time for the patient. It is envisaged that this information, combined with the costs associated with the procedure, will also provide valuable economic data to help justify the use of VERSAJET™ from a financial perspective and support the future commercial success of the device.
- Conditions
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
- Being tested
- Versajet Hydrosurgery System, Conventional surgical debridement techniques
- Keywords
- Debridement, hydrosurgery, Versajet, leg ulcer
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versajet Hydrosurgery SystemDevice
Debridement with Versajet Hydrosurgery System
Conventional surgical debridement techniquesProcedure or surgery
Conventional surgical debridement with scalpel and pulse lavage
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Debridement with Versajet Hydrosurgery system Receives: Device: Versajet Hydrosurgery System |
| Control | Other | Conventional surgical debridement techniques Receives: Procedure: Conventional surgical debridement techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the average skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques.
Measured: During surgery
Secondary outcomes (2)
Difference in the total average time of the debridement procedure, including preparation, skin-to-skin and recovery, according to the debridement technique.
Measured: Entry into OR holding area to discharge from recovery room
Difference in outcomes of the procedure, according to the debridement technique in terms of; time to wound closure, number of subsequent debridements, number of serious adverse events
Measured: 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startApr 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wayne J Caputo, DPM, Principal investigator, Clara Maass Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521027
- Sponsor's protocol ID
- CE025VJT
- Status last verified
- Feb 2018
- First submitted
- 23 Aug 2007
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Comparative, Single-centre Clinical Evaluation to Investigate the Skin-to-skin Time of the First Surgical Debridement of Lower Extremity Ulcers With VERSAJET™ Hydrosurgery System and Conventional Debridement Techniques.
- ClinicalTrials.gov ID
- NCT00521027
- Acronym / sponsor ID
- CE025VJT
- Conditions
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
- Keywords
- Debridement, hydrosurgery, Versajet, leg ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is prospective, comparative clinical evaluation to investigate whether there is a reduction in the skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques. Skin-to-skin time is defined as the time of incision to the end time of debridement (wound ready for dressing application). Conventional debridement is defined as scalpel plus pulse lavage.
The purpose of this comparison is to demonstrate the resource savings which VERSAJET™ may provide in terms of operating room (OR) and personnel time, in addition to the potential to reduce the procedure, and possibly anaesthetic, time for the patient. It is envisaged that this information, combined with the costs associated with the procedure, will also provide valuable economic data to help justify the use of VERSAJET™ from a financial perspective and support the future commercial success of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Versajet Hydrosurgery SystemDebridement with Versajet Hydrosurgery system |
| Control | Other | Procedure: Conventional surgical debridement techniquesConventional surgical debridement techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versajet Hydrosurgery SystemDebridement with Versajet Hydrosurgery System | Device | Treatment |
| Conventional surgical debridement techniquesConventional surgical debridement with scalpel and pulse lavage | Procedure or surgery | Control |
Primary outcome
Reduction in the average skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques.
Time frame: During surgery
2 secondary outcomes
Difference in the total average time of the debridement procedure, including preparation, skin-to-skin and recovery, according to the debridement technique.
Time frame: Entry into OR holding area to discharge from recovery room
Difference in outcomes of the procedure, according to the debridement technique in terms of; time to wound closure, number of subsequent debridements, number of serious adverse events
Time frame: 3 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne J Caputo, DPM principal investigator
Clara Maass Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Versajet Hydrosurgery System and Conventional surgical debridement techniques in people with Diabetic Foot and Varicose Ulcer, run by Smith & Nephew, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the average skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques. (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.