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

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.

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