Microenvironment in Patients Undergoing Non-traumatic 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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07384689

Acronym

MiAMII

Enrollment

Registered

2026-02-03

Start date

2025-08-01

Completion date

2028-01-01

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Amputation Above Knee

Brief summary

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

Interventions

DEVICEciNPWT

Closed incision negative pressure wound therapy

OTHERSSD

Standard stump dressing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ischemia	Within 72 hours postoperatively	Concentration of ischemic metabolites: Glucose, Lactate, Pyruvate and Glycerol

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026