Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.

Not Applicable

Completed

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.

Recruitment & Eligibility

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