Back to resultsEvaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary Purpose
Diabetes, Foot Ulcers
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NPWT System
NPWT system
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Diabetic foot ulcers
Eligibility Criteria
Inclusion Criteria:
- Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- 1 cm2 ≤ Wound size ≤ 200 cm2
- Male or female, 18 years and above
- Signed Informed Consent Form
- Subject understands the written subject Information
Exclusion Criteria:
- Need for frequent dressing changes, i.e.<72 hours between the changes
- Dry wounds
- Critical ischemia (for wound healing) according to investigator's judgement
- Malignancy in the wound and/or wound margin
- Target ulcer previous not successfully treated with NPWT within 48 hours
- Poorly controlled diabetes according to investigators judgement.
- Osteomyelitis which has been left untreated
- Infection which has been left untreated
- Unexplored fistula
- > 10% surface area necrotic tissue with eschar present after debridement
- High risk for bleeding complications
- Exposed major blood vessels, organs or nerves
- Current or within 3 months treatment with chemotherapy or irradiation
- Known hypersensitivity to the dressing material
- Expected technically impossible to seal the film to maintain a vacuum for treatment
- Expected non compliance with the Clinical Investigation Plan
- Pregnancy
- Subjects not suitable for the investigation according to the investigator's judgement
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Sites / Locations
- Freeman Hospital
- Norfolk & Norwich University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NPWT system
Arm Description
Negative pressure wound therapy
Outcomes
Primary Outcome Measures
Mean Change in Wound Area.
Measured by tracing of wound and measured by planimeter.
Secondary Outcome Measures
Full Information
NCT ID
NCT01011387
First Posted
November 4, 2009
Last Updated
March 20, 2012
Sponsor
Molnlycke Health Care AB
1. Study Identification
Unique Protocol Identification Number
NCT01011387
Brief Title
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary objective
To assess wound healing and granulation tissue formation when using the NPWT system
Secondary objectives
To investigate the pain level at dressing removal
To visually check exudate removal
To investigate the ease of use for the subject and care giver when using the NPWT system
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Foot Ulcers
Keywords
Diabetic foot ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPWT system
Arm Type
Other
Arm Description
Negative pressure wound therapy
Intervention Type
Procedure
Intervention Name(s)
NPWT System
Intervention Description
Dressing change 3 times per week
Intervention Type
Device
Intervention Name(s)
NPWT system
Intervention Description
3 dressing changes/week for maximum 4 weeks.
Primary Outcome Measure Information:
Title
Mean Change in Wound Area.
Description
Measured by tracing of wound and measured by planimeter.
Time Frame
From baseline to maximum 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment
1 cm2 ≤ Wound size ≤ 200 cm2
Male or female, 18 years and above
Signed Informed Consent Form
Subject understands the written subject Information
Exclusion Criteria:
Need for frequent dressing changes, i.e.<72 hours between the changes
Dry wounds
Critical ischemia (for wound healing) according to investigator's judgement
Malignancy in the wound and/or wound margin
Target ulcer previous not successfully treated with NPWT within 48 hours
Poorly controlled diabetes according to investigators judgement.
Osteomyelitis which has been left untreated
Infection which has been left untreated
Unexplored fistula
> 10% surface area necrotic tissue with eschar present after debridement
High risk for bleeding complications
Exposed major blood vessels, organs or nerves
Current or within 3 months treatment with chemotherapy or irradiation
Known hypersensitivity to the dressing material
Expected technically impossible to seal the film to maintain a vacuum for treatment
Expected non compliance with the Clinical Investigation Plan
Pregnancy
Subjects not suitable for the investigation according to the investigator's judgement
Subjects previously included in this investigation
Subjects included in other ongoing clinical investigation at present or during the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Stansby, MD, Prof.
Organizational Affiliation
Freeman Hospital, Newcastle upon tyne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freeman Hospital
City
Newcastle upon Tyne,
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norfolk,
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
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