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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Wound is closed or left open to heal secondarily after amputation.
Tampere University Hospital
Tampere, Finland
RECRUITINGWound healed
Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit
Time frame: 3 months
Complications
Percentage of patients experiencing complication during 3 month follow-up
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
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