Evaluating outcomes after toe amputation in diabetic patients
Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.
This study tests whether closing or leaving open the wounds after toe amputation helps diabetic patients with foot infections heal better and feel more functional over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 1 site (Tampere) |
| Trial ID | NCT05855980 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the outcomes of toe amputation in patients with diabetes suffering from foot infections. Participants are randomly assigned to have their wounds either closed or left open during the amputation procedure. The study aims to assess wound healing and functional outcomes over a three-month follow-up period, utilizing patient-reported outcome measures. Additionally, the trial explores the use of thermal imaging technology to predict complications post-amputation.
Who should consider this trial
Good fit: Ideal candidates are diabetic patients requiring toe amputation due to infection.
Not a fit: Patients with deep foot infections, sepsis, or those undergoing amputation for non-infectious reasons will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve wound healing and functional recovery for diabetic patients undergoing toe amputation.
How similar studies have performed: Other studies have explored similar interventions, but the specific use of thermal imaging in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Tampere
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Principal investigator: Miska Vuorlaakso, PhD — Tampere University Hospital
- Study coordinator: Miska Vuorlaakso, PhD
- Email: miska.vuorlaakso@gmail.com
- Phone: +3583311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.