NCT07384689

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Aug 2025Jan 2028

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

January 26, 2026

Last Update Submit

February 10, 2026

Conditions

Lower Limb Amputation Above Knee

Outcome Measures

Primary Outcomes (1)

  • Ischemia

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

    Within 72 hours postoperatively

Study Arms (2)

ciNPWT

ACTIVE COMPARATOR
Device: ciNPWT

SSD

ACTIVE COMPARATOR
Other: SSD

Interventions

ciNPWTDEVICE

Closed incision negative pressure wound therapy

ciNPWT
SSDOTHER

Standard stump dressing

SSD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Cognitive ability to provide informed consent
  • Scheduled for transfemoral amputation at Aarhus University Hospital

You may not qualify if:

  • Non-vascular indication of amputation
  • Already amputated on the contralateral leg
  • Insufficient flap perfusion
  • Allergic or sensitivity to silver or acrylic adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Interventions

Silver Sulfadiazine

Intervention Hierarchy (Ancestors)

SulfadiazineBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior registrar at the department of Orthopaedic Surgery, Amputation and infections unit, PhD

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

DK(1)