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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01011387
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : March 21, 2012
Last Update Posted : March 21, 2012
Information provided by (Responsible Party):
Molnlycke Health Care AB

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

Condition or disease Intervention/treatment Phase
Diabetes Foot Ulcers Procedure: NPWT System Device: NPWT system Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
NPWT system
Negative pressure wound therapy
Procedure: NPWT System
Dressing change 3 times per week
Device: NPWT system
3 dressing changes/week for maximum 4 weeks.

Primary Outcome Measures :
  1. Mean Change in Wound Area. [ Time Frame: From baseline to maximum 4 weeks ]
    Measured by tracing of wound and measured by planimeter.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01011387

United Kingdom
Freeman Hospital
Newcastle upon Tyne,, United Kingdom
Norfolk & Norwich University Hospital
Norfolk,, United Kingdom
Sponsors and Collaborators
Molnlycke Health Care AB
Principal Investigator: Gerard Stansby, MD, Prof. Freeman Hospital, Newcastle upon tyne

Responsible Party: Molnlycke Health Care AB Identifier: NCT01011387     History of Changes
Other Study ID Numbers: NPWT 01
First Posted: November 11, 2009    Key Record Dates
Results First Posted: March 21, 2012
Last Update Posted: March 21, 2012
Last Verified: March 2012

Keywords provided by Molnlycke Health Care AB:
Diabetic foot ulcers

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases