Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: NPWT system Negative pressure wound therapy |
Procedure: NPWT System
Dressing change 3 times per week
Device: NPWT system
3 dressing changes/week for maximum 4 weeks.
|
Outcome Measures
Primary Outcome Measures
- Mean Change in Wound Area. [From baseline to maximum 4 weeks]
Measured by tracing of wound and measured by planimeter.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Freeman Hospital | Newcastle upon Tyne, | United Kingdom | ||
| 2 | Norfolk & Norwich University Hospital | Norfolk, | United Kingdom |
Sponsors and Collaborators
- Molnlycke Health Care AB
Investigators
- Principal Investigator: Gerard Stansby, MD, Prof., Freeman Hospital, Newcastle upon tyne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NPWT 01
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Negative Pressure Wound Therapy System |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 16 |
| COMPLETED | 10 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | NPWT System |
|---|---|
| Arm/Group Description | Negative Pressure Wound Therapy |
| Overall Participants | 16 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
9
56.3%
|
| >=65 years |
7
43.8%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
18.8%
|
| Male |
13
81.3%
|
Outcome Measures
| Title | Mean Change in Wound Area. |
|---|---|
| Description | Measured by tracing of wound and measured by planimeter. |
| Time Frame | From baseline to maximum 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | NPWT System |
|---|---|
| Arm/Group Description | Negative Pressure Wound Therapy |
| Measure Participants | 16 |
| Mean (Full Range) [cm2] |
-33.7
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | NPWT System | |
| Arm/Group Description | Negative Pressure Wound Therapy | |
All Cause Mortality |
||
| NPWT System | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| NPWT System | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| NPWT System | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/16 (37.5%) | |
| General disorders | ||
| Diarrhoea+nausea | 1/16 (6.3%) | |
| Developed MRSA | 2/16 (12.5%) | |
| Skin and subcutaneous tissue disorders | ||
| Ulceration plantar aspect | 1/16 (6.3%) | |
| Further deterioration of wound | 1/16 (6.3%) | |
| VAC could not maintain suction as surrounding skin deteriorated and seal could not be maintained | 1/16 (6.3%) | |
| Wound deteriorated | 1/16 (6.3%) | |
| Surgical and medical procedures | ||
| Further revision required fourth toe Ulceration plantar aspect | 1/16 (6.3%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Jenny Thorell |
|---|---|
| Organization | Mölnlycke Health Care AB |
| Phone | 0046 31 7223000 |
| jenny.thorell@molnlycke.com |
- NPWT 01