This study investigates whether, compared to standard treatment, immediate restoration of blood flow (revascularization) can reduce complications and improve diabetic foot ulcer healing.
Background: In approximately 80% of diabetes-related lower extremity amputations, patients suffer from a foot ulcer, often caused by lower extremity arterial disease. Due to lower extremity arterial disease (LEAD), diabetic patients with foot ulcers often require lower limb amputation. Achieving arterial supply (revascularization) to the ulcer is the most important factor in healing the diabetic foot ulcer and reduces the risk of amputation. The current standard of care recommends revascularization after six weeks in patients with low-grade arterial disease of the lower extremities and nonhealing foot ulcer. The aim of this study is to demonstrate that in patients with low grade arterial disease of the lower extremities and diabetic foot ulcers, immediate revascularization results in fewer cardiovascular problems and amputations, as well as improved ulcer healing, compared to the current standard of care. Study procedure: After inclusion in the study, participants will be randomized into the control arm or the active arm. In the control arm standard wound care will be performed. In the active arm, revascularization will be performed on top of standard wound care within 7 days after randomization. Post-revascularization analysis on ankle- and toe pressure, laboratory analysis, and wound care team assessment and therapy will be performed 24 h post operation. Follow up will be on 45, 90, 180 and 365 day for patients of both arms, where ankle- and toe pressure, laboratory analysis, and wound care team assessment and therapy will be performed. Number of Participants: 240 participants in total, 120 per treatment arm Study duration: 4 years Study Centre(s): International multi-centre study with approximately 8-12 centres Participating countries: Switzerland, Germany
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Depending on the condition of the patients, patients will have either endovascular or surgical revascularization
Standard wound care according to guidelines
Clinic for Angiology, University of Basel
Basel, Switzerland
University Clinic for Angiology, University Hospital Inselspital, Berne
Bern, Switzerland
Angiologie, Luzerner Kantonsspital
Lucerne, Switzerland
Clinic for Vascular Surgery, Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Number of patients with cardiovascular death
Time frame: up to 12 months
Number of patients with non-fatal myocardial infarction or all-cause stroke
Time frame: up to 12 months after randomization
Number of patients with major amputation
Time frame: up to 12 months after randomization
Number of patients with Minor amputation
Time frame: up to 12 months after randomization
Number of patients with missed diabetic foot ulcer healing
i.e. Incomplete epithelization of the index ulcer at 90 days
Time frame: 90 days after randomization
Number of patients with delayed diabetic foot ulcer healing
Reduction of wound size of less than 50% at 45 days
Time frame: 45 days after randomization
Number of patients with new ulcer of the index foot
Time frame: up to 12 months after randomization
Number of patients with all clinically-driven revascularizations at the index limb
excluding primary revascularization in the immediate re-vascularization group
Time frame: up to 12 months after randomization
Each component of the primary outcome individually
Primary outcome 1 to 6
Time frame: up to 12 months after randomization
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Number of in-hospital days and costs
(based on Disease-Related Group codes) as a measure of health service utilization
Time frame: up to 12 months after randomization
Change in quality of life (QoL) assessed by the Cardiff Wound Impact Schedule questionnaire
Scores are transformed onto a scale of 0 - 100, a high score represents a 'good' QoL and a low score represent a 'poor' QoL
Time frame: from baseline to 90 days and 12 months after randomization
Number of patients with major amputation-free survival
death of any cause or major amputation
Time frame: up to 12 months after randomization
Number of patients with all-cause death
Time frame: up to 12 months after randomization