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

Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011387
• Other study ID #: NPWT 01
• Status: Completed
• Phase: N/A
• First received: November 4, 2009
• Last updated: March 20, 2012
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2012
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Foot Ulcer
• Foot Ulcers

Intervention

Procedure:
• NPWT System
Dressing change 3 times per week

Device:
• NPWT system
3 dressing changes/week for maximum 4 weeks.

Locations

Country	Name	City	State
United Kingdom	Freeman Hospital	Newcastle upon Tyne,
United Kingdom	Norfolk & Norwich University Hospital	Norfolk,

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Wound Area.	Measured by tracing of wound and measured by planimeter.	From baseline to maximum 4 weeks	No