Amputation stump microenvironment in people having a non-traumatic above-knee amputation
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
NA · University of Aarhus · NCT07384689
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT07384689 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus N
- Aarhus University Hospital — Aarhus N, Denmark (RECRUITING)
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.
Conditions: Lower Limb Amputation Above Knee