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Tracking Information | |||||
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First Received Date ICMJE | November 4, 2009 | ||||
Last Updated Date | March 20, 2012 | ||||
Start Date ICMJE | January 2010 | ||||
Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Mean Change in Wound Area. [ Time Frame: From baseline to maximum 4 weeks ] [ Designated as safety issue: No ] Measured by tracing of wound and measured by planimeter. |
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Original Primary Outcome Measures ICMJE |
To assess wound healing and granulation tissue formation when using the Avance™ NPWT system [ Time Frame: 3 times per week during 4 weeks ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT01011387 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds. | ||||
Official Title ICMJE | A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a NPWT (Negative Pressure Wound Therapy) System to be Used in the Treatment of Diabetic Foot Ulcers (DFUs) Including Post Amputation Wounds Associated With Diabetes. | ||||
Brief Summary | Primary objective
Secondary objectives
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Detailed Description | The investigation is designed as a prospective, open, non-controlled clinical investigation. Wounds to be treated under this protocol should be Diabetic foot ulcers (DFUs) or post amputation wounds associated with diabetes in hospitalized subjects or subjects treated at home. One ulcer or post amputation wound per subject will be treated for a maximum duration of 4 weeks. All subjects will receive negative pressure treatment with the NPWT system, -120 mm Hg. In total, 10-15 subjects at two sites will be enrolled provided that they fulfill all the inclusion criteria and none of the exclusion criteria and have signed and dated a written informed consent. The subjects will be consecutively allocated to a specific subject identification code and the recruitment will be competitive. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation. Pain level and subject/investigator convenience will be assessed by convenience surveys. An evaluable subject is defined as a subject completing the investigation with 4 weeks of treatment, a subject healed before 4 weeks of treatment or if the investigator judge that the wound has adequately responded on NPWT before 4 weeks and that continued treatment can be made with alternative treatment. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms | NPWT system
Negative pressure wound therapy
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 16 | ||||
Completion Date | July 2010 | ||||
Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01011387 | ||||
Other Study ID Numbers ICMJE | NPWT 01 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Molnlycke Health Care AB | ||||
Study Sponsor ICMJE | Molnlycke Health Care AB | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Molnlycke Health Care AB | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |