Toe Amputations in Patients With Diabetes

Last updated: December 5, 2023
Sponsor: Tampere University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Treatment

Wound closure

Clinical Study ID

NCT05855980
R22101
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Toe amputation due to diabetic foot infection

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 102
Treatment Group(s): 1
Primary Treatment: Wound closure
Phase:
Study Start date:
May 22, 2023
Estimated Completion Date:
May 01, 2025

Study 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.

Connect with a study center

  • Tampere University Hospital

    Tampere,
    Finland

    Active - Recruiting

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