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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a NPWT (Negative Pressure Wound Therapy) System to be Used in the Treatment of Diabetic Foot Ulcers (DFUs) Including Post Amputation Wounds Associated With Diabetes.

Conditions
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Diabetes, Foot Ulcers

Intervention / Treatment
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* Procedure: NPWT System
* Device: NPWT system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NPWT system<br>Negative pressure wound therapy | Procedure: NPWT System<br>* Dressing change 3 times per week<br>Device: NPWT system<br>* 3 dressing changes/week for maximum 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Wound Area. | Measured by tracing of wound and measured by planimeter. | From baseline to maximum 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot ulcers