An interventional study of NPWT System and NPWT system in Diabetes and Foot Ulcers, sponsored by Molnlycke Health Care AB. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-21.
Sponsored by Molnlycke Health Care AB · Not applicable, Interventional, and Treatment
Primary objective
Secondary objectives
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.
691 studies on the registry are indexed under Foot Ulcer; 96 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 562 interventional studies indexed under Foot Ulcer.
Browse Foot Ulcer studies →Molnlycke Health Care AB is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Negative pressure wound therapy
Procedure: NPWT System · Device: NPWT system
Dressing change 3 times per week
3 dressing changes/week for maximum 4 weeks.
Mean Change in Wound Area.
Measured by tracing of wound and measured by planimeter.
Time frame: From baseline to maximum 4 weeks
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.
| Milestone | Negative Pressure Wound Therapy System |
|---|---|
| Started | 16 |
| Completed | 10 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Adverse event | 2 |
| Withdrew: Protocol violation | 1 |
Measured by tracing of wound and measured by planimeter.
| cm2 | NPWT System |
|---|---|
| Mean Change in Wound Area. | -33.7 (-82 to 15) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NPWT System | — | 0/16 (0%) | 6/16 (37.5%) |
| Event | NPWT System |
|---|---|
| Developed MRSAGeneral disorders | 2/16 |
| Further revision required fourth toe Ulceration plantar aspectSurgical and medical procedures | 1/16 |
| Ulceration plantar aspectSkin and subcutaneous tissue disorders | 1/16 |
| Further deterioration of woundSkin and subcutaneous tissue disorders | 1/16 |
| VAC could not maintain suction as surrounding skin deteriorated and seal could not be maintainedSkin and subcutaneous tissue disorders | 1/16 |
| Diarrhoea+nauseaGeneral disorders | 1/16 |
| Wound deterioratedSkin and subcutaneous tissue disorders | 1/16 |
| Age, Categorical(Participants) | NPWT System |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 7 |
| Sex: Female, Male(Participants) | NPWT System |
|---|---|
| Female | 3 |
| Male | 13 |
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Molnlycke Health Care AB