N/A
N=16
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Diabetes · Foot Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01011387 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Mean Change in Wound Area. — -33.7 cm2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NPWT System (Procedure); NPWT system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Wound Area. |
-33.7 | — |
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
Eligibility Criteria
Inclusion Criteria
- Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- 1 cm2 ≤ Wound size ≤ 200 cm2
- Male or female, 18 years and above
- Signed Informed Consent Form
- Subject understands the written subject Information
Exclusion Criteria
- Need for frequent dressing changes, i.e. 10% surface area necrotic tissue with eschar present after debridement
- High risk for bleeding complications
- Exposed major blood vessels, organs or nerves
- Current or within 3 months treatment with chemotherapy or irradiation
- Known hypersensitivity to the dressing material
- Expected technically impossible to seal the film to maintain a vacuum for treatment
- Expected non compliance with the Clinical Investigation Plan
- Pregnancy
- Subjects not suitable for the investigation according to the investigator's judgement
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Data sourced from ClinicalTrials.gov (NCT01011387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.