Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure

Not Applicable

• Conditions: E11.74; MedDRA - 10060734: Diabetic foot; E10.74; E11.75; E10.75

• Registration Number: DRKS00000059
• Lead Sponsor: Private Universität Witten/Herdecke gGmbHMedizinische Fakultät

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1- Diabetes mellitus type I, II or III as defined by the necessity for antidiabetic drugs since >= 12 months

2- All wounds corresponded to University of Texas grade 2 or 3 in depth
- either a chronic wound
(which is planned to receive surgical debridement)
- or an amputation wound (which results from a planned below-ankle amputation because of diabetic foot syndrome)

3- Written informed consent

Exclusion Criteria

1- Untreated or refractory phlegmona or osteomyelitis of the wound

2- Presence of necrotic tissue that cannot be debrided

3- Evidence of inadequate leg perfusion (macroangiopathy)

4- Indication for above-ankle amputation of the same extremity

5- Age <18 years

6- Non compliance

7- Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time until complete (100%) wound closure (including photo documentation and blinded assessment) without any need for drainage or dressing

Secondary Outcome Measures

Name	Time	Method
-Pain in wound area (until wound closure and at 12 months)<br>-Wound size over time (percentage change)<br>-Time until wound bed preparation (i.e. 95% granulation tissue)<br>-Recurrence of wound or ulcer at same site<br>-Number of dressing changes<br>-Length of hospital stay<br>-Time until orthopedic footwear supply possible<br>-Time until return to work<br>-Quality-of-life during treatment <br>-Quality of life after Healing (at 6 and 12 months)<br>-Patient satisfaction <br>-Costs (in and out hospital)<br>-Secondary resections and amputations (incidence and dimension)<br>-Complication rates (local and systemic)<br>-Total complication rate<br>-Mortality of any cause (within 12 months)