Actively Recruiting
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
Led by University of Aarhus · Updated on 2026-02-12
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the microenvironment of the amputation stump in patients undergoing non-traumatic transfemoral amputation, focusing on ischemia, inflammation, and antibiotic presence. The study compares diabetic and non-diabetic patients to better understand local tissue conditions after surgery. Participants will be randomly assigned to one of two groups receiving different wound care treatments after amputation. One group will receive closed incision negative pressure wound therapy (ciNPWT), while the other will receive standard stump dressing (SSD). The study measures ischemia within 72 hours after surgery. During the trial, patients will have microdialysis and tissue sampling performed to analyze the local stump environment. Researchers will monitor ischemia and collect data within the first three days post-operation. Participation involves assessments related to wound healing and local tissue status, with follow-up continuing until study completion in 2028.
CONDITIONS
Brief Title
Microenvironment in Patients Undergoing Non-traumatic Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Cognitive ability to provide informed consent
- Scheduled for transfemoral amputation at Aarhus University Hospital
You will not qualify if you...
- Non-vascular indication of amputation
- Already amputated on the contralateral leg
- Insufficient flap perfusion
- Allergic or sensitivity to silver or acrylic adhesives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours postoperatively
Participants undergo non-traumatic transfemoral amputation surgery followed by immediate post-operative care including application of either closed incision negative pressure wound therapy or standard stump dressing.
1 surgical procedure and immediate post-operative monitoring
Duration - Up to 72 hours postoperatively
Participants are monitored after surgery to assess ischemia and wound healing outcomes.
Approximately 2 follow-up visits within 72 hours
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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