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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01011387
First received: November 4, 2009
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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 Intervention
Diabetes
Foot Ulcers
Procedure: NPWT System
Device: NPWT system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Mean Change in Wound Area. [ Time Frame: From baseline to maximum 4 weeks ] [ Designated as safety issue: No ]
    Measured by tracing of wound and measured by planimeter.


Enrollment: 16
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011387

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

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01011387     History of Changes
Other Study ID Numbers: NPWT 01
Study First Received: November 4, 2009
Results First Received: December 22, 2010
Last Updated: March 20, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Molnlycke Health Care AB:
Diabetic foot ulcers

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

ClinicalTrials.gov processed this record on November 23, 2014