Timing of Revascularization in Patients With Diabetic Foot Ulcer &

Status Active, not recruiting

Clinical Trial Summary

This study investigates whether, compared to standard treatment, immediate restoration of blood flow (revascularization) can reduce complications and improve diabetic foot ulcer healing.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04939038
Study type	Interventional
Source	Insel Gruppe AG, University Hospital Bern
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 25, 2022
Completion date	January 24, 2026

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Timing of Revascularization in Patients With Diabetic Foot Ulcer and Non-critical Peripheral Artery Disease — DIFU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms