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

Not Applicable

• Conditions: Chronic diabetic foot wounds after debridement avital tissue componentsChronic diabetic foot wounds after amputation below the articulatio talocruralis; E10.74; E10.75; E11.74; E11.75

• Registration Number: DRKS00003347
• Lead Sponsor: Private Universität Witten / Herdecke gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-22
• Study Completion: 2015-04-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of achieved and confirmed wound closures within a maximum treatment time of 16 weeks plus the time until complete wound closure (in days)<br>The wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material.<br>The closure must remain at least for a period of 14 days.

Secondary Outcome Measures

Name	Time	Method
Time until optimal preparation of the wound bed for further therapy (granulation of at least 95%);<br>Time to reach a complete wound closure within the observation period of 6 months;<br>Recurrences; Amputations (appearance and dimension); Wound size over time;<br>Proportion of wound tissue qualities over time; all SAEs within 6 months; wound specific and device specific AEs within the active study treatment time of 16 weeks or until end of therapy; Pain (NRS) within the active study treatment time of 16 weeks or until end of therapy; Quality of Life (EQ-5D) within 6 months; direct costs (medical and non-medical); indirect costs