Amputation, Diabetic Foot, Infections
Conditions
Keywords
Diabetic foot, Infection, Amputation
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.
Interventions
PROCEDUREWound closure
Wound is closed or left open to heal secondarily after amputation.
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healed | 3 months | Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 3 months | Percentage of patients experiencing complication during 3 month follow-up |
| 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: 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: 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. |
Countries
Finland
Contacts
Primary ContactMiska Vuorlaakso, PhD
Outcome results
None listed