Diabetes, Foot Ulcers
Conditions
Keywords
Diabetic foot ulcers
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.
Interventions
PROCEDURENPWT System
Dressing change 3 times per week
DEVICENPWT system
3 dressing changes/week for maximum 4 weeks.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment 2. 1 cm2 ≤ Wound size ≤ 200 cm2 3. Male or female, 18 years and above 4. Signed Informed Consent Form 5. Subject understands the written subject Information
Exclusion criteria
1. Need for frequent dressing changes, i.e.\<72 hours between the changes 2. Dry wounds 3. Critical ischemia (for wound healing) according to investigator's judgement 4. Malignancy in the wound and/or wound margin 5. Target ulcer previous not successfully treated with NPWT within 48 hours 6. Poorly controlled diabetes according to investigators judgement. 7. Osteomyelitis which has been left untreated 8. Infection which has been left untreated 9. Unexplored fistula 10. \> 10% surface area necrotic tissue with eschar present after debridement 11. High risk for bleeding complications 12. Exposed major blood vessels, organs or nerves 13. Current or within 3 months treatment with chemotherapy or irradiation 14. Known hypersensitivity to the dressing material 15. Expected technically impossible to seal the film to maintain a vacuum for treatment 16. Expected non compliance with the Clinical Investigation Plan 17. Pregnancy 18. Subjects not suitable for the investigation according to the investigator's judgement 19. Subjects previously included in this investigation 20. Subjects included in other ongoing clinical investigation at present or during the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Wound Area. | From baseline to maximum 4 weeks | Measured by tracing of wound and measured by planimeter. |
Countries
United Kingdom
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.
Participants by arm
| Arm | Count |
|---|---|
| NPWT System Negative Pressure Wound Therapy | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | NPWT System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Mean Change in Wound Area.
Measured by tracing of wound and measured by planimeter.
Time frame: From baseline to maximum 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NPWT System | Mean Change in Wound Area. | -33.7 cm2 |