Clinical trial NCT01011387: Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Foot Ulcers
Keywords: Diabetic foot ulcers
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Mean Change in Wound Area.
timeFrame: From baseline to maximum 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle upon Tyne,
country: United Kingdom
facility: Freeman Hospital
city: Norfolk,
country: United Kingdom
facility: Norfolk & Norwich University Hospital
Study officials:
affiliation: Freeman Hospital, Newcastle upon tyne
name: Gerard Stansby, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: