Toe Amputations in Patients With Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot, Infections, Amputation

Intervention / Treatment
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* Procedure: Wound closure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Closed wound<br>Wound is closer immediately after amputation (instead healing secondarily) | Procedure: Wound closure<br>* Wound is closed or left open to heal secondarily after amputation.<br>|
| No Intervention: Open wound<br>Wound is left to heal secondarily | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healed | Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Percentage of patients experiencing complication during 3 month follow-up | 3 months | 
| Functional outcome: 15D | 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. | 3 months | 
| Functional outcome: TESS | 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. | 3 months | 
| Functional outcome: FHSQ | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot, Infection, Amputation