Randomized, controlled clinical trial evaluating the efficacy and clinical effectiveness of negative pressure wound therapy for the treatment of diabetic foot wounds when compared to standard wound therapyA study project with a pragmatic approach to evaluate the negative pressure wound therapy in the medical treatment sectors in Germany - DiaFu

Private Universität Witten / Herdecke gGmbH0 个研究点目标入组 360 人开始时间: 2011年11月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Presence of diabetes mellitus; Presence of a foot wound (chronic wounds; amputational 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

•Age <18 years; Pregnancy; Non-Compliance; Allergies regarding the release of substances from components of each treatment arm; Severe anemia, which 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 inclusio; 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

发起方

Private Universität Witten / Herdecke gGmbH