Microenvironment in Patients Undergoing Non-traumatic Amputation (MiAMII)

University of Aarhus

Status: Enrolling

Conditions: Lower Limb Amputation Above Knee

Treatments: Other: SSD; Device: ciNPWT

Study type: Interventional

Funder types: Other

Identifiers

NCT07384689

115908

Details and patient eligibility

About

The microenvironment of the amputation stump in patients undergoing non-traumatic transfemoral amputation will be investigated with a combination of microdialysis and tissue sampling.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

ciNPWT

Active Comparator group

Treatment:

Device: ciNPWT

SSD

Active Comparator group

Treatment:

Other: SSD