Trial Outcomes & Findings for Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds. (NCT NCT01011387)
NCT ID: NCT01011387
Last Updated: 2012-03-21
Results Overview
Measured by tracing of wound and measured by planimeter.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
From baseline to maximum 4 weeks
Results posted on
2012-03-21
Participant Flow
Investigation period: Feb 2010 - July 2010. In- and/or out-patients at two centers in UK were included in this investigation. Subjects included were 18 years and above with DFU including post amputation wounds associated with diabetes.Dressing changes were made 3 times/week for maximum 4 weeks.
Participant milestones
| Measure |
Negative Pressure Wound Therapy System
The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Negative Pressure Wound Therapy System
The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Baseline characteristics by cohort
| Measure |
NPWT System
n=16 Participants
Negative Pressure Wound Therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to maximum 4 weeksMeasured by tracing of wound and measured by planimeter.
Outcome measures
| Measure |
NPWT System
n=16 Participants
Negative Pressure Wound Therapy
|
|---|---|
|
Mean Change in Wound Area.
|
-33.7 cm2
Interval -82.0 to 15.0
|
Adverse Events
NPWT System
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NPWT System
n=16 participants at risk
Negative Pressure Wound Therapy
|
|---|---|
|
Surgical and medical procedures
Further revision required fourth toe Ulceration plantar aspect
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Ulceration plantar aspect
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Further deterioration of wound
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
VAC could not maintain suction as surrounding skin deteriorated and seal could not be maintained
|
6.2%
1/16
|
|
General disorders
Diarrhoea+nausea
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Wound deteriorated
|
6.2%
1/16
|
|
General disorders
Developed MRSA
|
12.5%
2/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Coordinating Investigator will be the lead author for the mail (primary) publication from this Investigation. For any abstract and/or manuscript the Investigators will be given at least 14 days review time before the intended submission of the document.
- Publication restrictions are in place
Restriction type: OTHER