Amputation stump microenvironment in people having a non-traumatic above-knee amputation
Official title: MiAMII Study - Microdialysis Acquired SaMpling of Ischemia, Inflammation and Antibiotics Locally in Amputation Stump: A Comparative Study in Diabetic and Non-Diabetic Patients Undergoing Non-Traumatic Transfemoral Amputation
Run by University of Aarhus · NCT07384689 · Data updated 2026-11-12
This project will test whether microdialysis and tissue sampling can map the local biological environment in people having non-traumatic above-knee amputations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07384689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who can give informed consent and are scheduled for a non-traumatic transfemoral amputation at Aarhus University Hospital, with adequate flap perfusion, are ideal candidates.
✕Probably not a fit
People with traumatic or non-vascular indications for amputation, an existing contralateral amputation, inadequate flap perfusion, or allergies to silver or acrylic adhesives are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients scheduled for non-traumatic transfemoral (above-knee) amputation at Aarhus University Hospital will have microdialysis catheters placed and tissue samples taken from the amputation stump. Participants will receive either closed-incision negative-pressure wound therapy (ciNPWT) or a standard surgical dressing (SSD) as the postoperative wound treatment. Collected samples will be analyzed for metabolites, inflammatory markers, and perfusion-related molecules to characterize the local microenvironment during early healing. The study aims to relate biochemical and tissue features to dressing type and early wound outcomes to inform postoperative care.
Why it matters
Potential benefit: If successful, the findings could identify local tissue markers and dressing strategies that reduce infection and improve healing after above-knee amputation.
How similar studies have gone: Microdialysis and tissue sampling have been used in wound research and ciNPWT has shown benefits for some closed incisions, but applying these methods specifically to transfemoral amputation stumps is relatively novel with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * 18 years or older * Cognitive ability to provide informed consent * Scheduled for transfemoral amputation at Aarhus University Hospital Exclusion criteria * Non-vascular indication of amputation * Already amputated on the contralateral leg * Insufficient flap perfusion * Allergic or sensitivity to silver or acrylic adhesives
Where it's running
-
Aarhus University Hospital
Aarhus N, Denmark Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.