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Toe Amputations in Patients With Diabetes

Toe Amputations in Patients With Diabetes

Recruiting
18 years and older
All
Phase N/A

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Overview

This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.

Description

Patients with diabetes undergoing toe amputation due to infection, are recruited for this study. Based on randomization, wound is either closed or left open during the amputation procedure. If primary closure is not possible (e.g. deep abscess) and patient is randomized to closed group, delayed closure is performed when feasible. Patients are followed up in outpatient clinic 3 month after amputation. Primary outcome is wound healing that is evaluated during follow ups in the outpatient clinic. Functional outcome is evaluated with PROM questionnaires preoperatively and during the follow up.

Eligibility

Inclusion Criteria:

  • Toe amputation due to diabetic foot infection

Exclusion Criteria:

  • Deep foot infection
  • Sepsis
  • No clinical infection (amputation due to trauma, deformity or uninfected necrosis)

Study details
    Diabetic Foot
    Infections
    Amputation

NCT05855980

Tampere University Hospital

27 January 2024

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