Toe Amputations in Patients With Diabetes

Not Applicable

Recruiting

• Conditions: Infections; Amputation; Diabetic Foot
• Interventions: Procedure: Wound closure

• Registration Number: NCT05855980
• Lead Sponsor: Tampere University Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-12
• Study Start: 2023-05-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closed wound	Wound closure	Wound is closer immediately after amputation (instead healing secondarily)

Primary Outcome Measures

Name	Time	Method
Wound healed	3 months	Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit

Secondary Outcome Measures

Name	Time	Method
Complications	3 months	Percentage of patients experiencing complication during 3 month follow-up
Functional outcome: TESS	3 months	Toronto extremity salvage score (TESS) questionnaire 3 months after amputation and change compared to preoperative TESS score.; TESS is contains 30 questions (rated 1-5) measuring activity limitations. TESS result is a percentage of the maximum score, 100 representing normal activity.
Functional outcome: 15D	3 months	15D quality of life questionnaire 3 months after amputation and change compared to preoperative 15D score.; 15D is 15 dimensional questionnaire that provides score between 0 and 1 representing health related quality of life (HRQOL). Higher value represents better HRQOL.
Functional outcome: FHSQ	3 months	Foot health status questionnaire (FHSQ) 3 months after amputation and change compared to preoperative FHSQ score.; FHSQ consists of 19 questions that ultimately provide score 0-100 higher value representing better foot health status.

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland