Microenvironment in Patients Undergoing Non-traumatic Amp... | NCT07384689

Studies
Microenvironment in Patients Undergoing Non-traumatic Amputation

NCT07384689

Sponsor

University of Aarhus

Status

Recruiting

Last Update Posted

Feb 12, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Lower Limb Amputation Above Knee

Interventions

ciNPWT
SSD

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Jan 26, 2026

First Submission Date that Met QC Criteria

Jan 26, 2026

First Posted Date

Feb 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rehne Lessmann Hansen, Senior registrar at the department of Orthopaedic Surgery, Amputation and infections unit, PhD, Aarhus University HospitalPrincipal Investigator

Lead Sponsor

University of AarhusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ciNPWT	Active Comparator		Device: ciNPWT
SSD	Active Comparator		Other: SSD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ciNPWT	Device	Closed incision negative pressure wound therapy	ciNPWT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital	Recruiting	Aarhus N		8200	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D012837	Silver Sulfadiazine

Ancestor Terms

ID	Term
D013411	Sulfadiazine
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides

Browse Leaves

Not provided

Browse Branches

Not provided