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Recruiting

NCT Number: NCT07384689

Microenvironment in Patients Undergoing Non-traumatic Amputation

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

Recruiting

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Key information

Conditions

Lower Limb Amputation Above Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location status: Recruiting

Location contact

Rehne Dr., MD PhD

CONTACT

[email protected]

+4528128710

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ciNPWT

Device

Closed incision negative pressure wound therapy

SSD

Other

Standard stump dressing

Primary outcomes

  1. Ischemia

    Time frame: Within 72 hours postoperatively

    Concentration of ischemic metabolites: Glucose, Lactate, Pyruvate and Glycerol

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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

Acronym: MiAMII

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 3, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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