NCT01011387

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Foot Ulcers

Interventions

Type	Name	Description
PROCEDURE	NPWT System	Dressing change 3 times per week
DEVICE	NPWT system	3 dressing changes/week for maximum 4 weeks.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-11-11
• Last updated: 2012-03-21
• Results posted: 2012-03-21

Locations

2 sites across 1 country: United Kingdom