Toe Amputations in Patients With Diabetes (PANDORAT)

Tampere University Hospital

Status: Enrolling

Conditions: Diabetic Foot; Amputation; Infections

Treatments: Procedure: Wound closure

Study type: Interventional

Funder types: Other

Identifiers

NCT05855980

R22101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Closed wound

Active Comparator group

Description:

Wound is closer immediately after amputation (instead healing secondarily)

Treatment:

Procedure: Wound closure

Open wound

No Intervention group

Description:

Wound is left to heal secondarily