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Toe Amputations in Patients With Diabetes — PANDORAT  

Diabetic Foot Clinical Trial

Official title:
Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05855980
Study type Interventional
Source Tampere University Hospital
Contact Miska Vuorlaakso, PhD
Phone +3583311611
Email miska.vuorlaakso@gmail.com
Status Recruiting
Phase N/A
Start date May 22, 2023
Completion date May 1, 2025
View Details
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