Menu
Recruiting NCT07384689

Microenvironment in Patients Undergoing Non-traumatic Amputation

No phase Interventional Lower Limb Amputation Above Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ciNPWT, SSD.
Who it may be relevant to
Registry conditions: Lower Limb Amputation Above Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Device ciNPWT
    Closed incision negative pressure wound therapy
  • Other SSD
    Standard stump dressing

Primary outcome measures

  • Ischemia [Time frame: Within 72 hours postoperatively]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Aarhus University Hospital — Aarhus N

Identifiers

NCT: NCT07384689 · 115908

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗