Lower Limb Amputation Above KneeMiAMIINCT07384689
Microenvironment in Patients Undergoing Non-traumatic Amputation
A study testing ciNPWT and SSD in people with Lower Limb Amputation Above Knee, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Above Knee
- What is being tested?
- ciNPWT and SSD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Cognitive ability to provide informed consent
- Scheduled for transfemoral amputation at Aarhus University Hospital
Who cannot join
- Non-vascular indication of amputation
- Already amputated on the contralateral leg
- Insufficient flap perfusion
- Allergic or sensitivity to silver or acrylic adhesives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Rehne Dr., MD PhD, +4528128710, rehnhans@rm.dk
About this study
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
The microenvironment of the amputation stump in patients undergoing non-traumatic transfemoral amputation will be investigated with a combination of microdialysis and tissue sampling.
- Conditions
- Lower Limb Amputation Above Knee
- Being tested
- ciNPWT, SSD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciNPWTDevice
Closed incision negative pressure wound therapy
SSDOther
Standard stump dressing
| Study group | Role | What they receive |
|---|---|---|
| ciNPWT | Active comparator | Not described Receives: Device: ciNPWT |
| SSD | Active comparator | Not described Receives: Other: SSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia
Concentration of ischemic metabolites: Glucose, Lactate, Pyruvate and Glycerol
Measured: Within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Aug 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehne Lessmann Hansen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384689
- Sponsor's protocol ID
- 115908
- Acronym
- MiAMII
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07384689
- Acronym / sponsor ID
- MiAMII / 115908
- Conditions
- Lower Limb Amputation Above Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The microenvironment of the amputation stump in patients undergoing non-traumatic transfemoral amputation will be investigated with a combination of microdialysis and tissue sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciNPWT | Active comparator | Device: ciNPWT |
| SSD | Active comparator | Other: SSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Cognitive ability to provide informed consent
- Scheduled for transfemoral amputation at Aarhus University Hospital
Key exclusion criteria (4 listed)
- Non-vascular indication of amputation
- Already amputated on the contralateral leg
- Insufficient flap perfusion
- Allergic or sensitivity to silver or acrylic adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciNPWTClosed incision negative pressure wound therapy | Device | ciNPWT |
| SSDStandard stump dressing | Other | SSD |
Primary outcome
Ischemia
Time frame: Within 72 hours postoperatively
Concentration of ischemic metabolites: Glucose, Lactate, Pyruvate and Glycerol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciNPWT and SSD in people with Lower Limb Amputation Above Knee, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemia (time frame: Within 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.