Status:
COMPLETED
Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds
Lead Sponsor:
University of Witten/Herdecke
Collaborating Sponsors:
Kinetic Concepts, Inc.
Smith & Nephew Wound Management Inc
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
On behalf of a consortium of 19 health insurance companies the Institute for Research in Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and conducting a clinical s...
Detailed Description
This study project as part of a European tender has the aim to prove efficacy and effectiveness of negative pressure wound therapy in the management of patients with chronic diabetic foot wounds. The ...
Eligibility Criteria
Inclusion
- Presence of diabetes mellitus
- Presence of a foot wound (chronic wounds; amputation wounds) Wagner stage 2-4
- Existence of the foot wound for at least 4 weeks
- Signed informed consent form
- Patient's eligibility of NPWT in the opinion of the treating physician
Exclusion
- Age \<18 years
- Non-Compliance
- Pregnancy
- Allergies regarding the release of substances from components of each treatment arm
- Severe anemia, wich was not caused by an infection
- Simultaneous participation of patients in another interventional study / previous participation in the same study
- Use of NPWT systems to the study-related foot lesion within a period of 6 weeks prior to study inclusion
- Presence of necrotic tissue with eschar, which can not be removed
- Untreated osteitis or osteomyelitis
- Not examined / unexplored fistula
- Malignancy of the wound
- Exposed: nerves, blood vessels, anastomotic site
- ambulant NPWT of patients receiving anticoagulants (especially heparinization or marcumar therapy) or with otherwise highly impaired clotting function, which have a risk of circulatory relevant bleeding
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01480362
Start Date
November 1 2011
End Date
April 1 2015
Last Update
May 5 2020
Active Locations (42)
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1
Diabetes Klinik GmbH & Co KG
Bad Mergentheim, Germany, 97980
2
Evangelisches Krankenhaus, Königin Elisabeth Herzberge gGmbH
Berlin, Germany, 10365
3
Franziskus-Krankenhaus Berlin, Abteilung für Innere Medizin
Berlin, Germany, 10787
4
Klinikum Bielefeld, Klinik für Allgemeine und Innere Medizin
Bielefeld, Germany, 33604