NCT05855980

Brief Summary

This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

April 5, 2023

Last Update Submit

December 5, 2023

Conditions

Diabetic FootInfectionsAmputation

Keywords

Diabetic footInfectionAmputation

Outcome Measures

Primary Outcomes (1)

  • Wound healed

    Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit

    3 months

Secondary Outcomes (4)

  • Complications

    3 months

  • Functional outcome: 15D

    3 months

  • Functional outcome: TESS

    3 months

  • Functional outcome: FHSQ

    3 months

Study Arms (2)

Closed wound

ACTIVE COMPARATOR

Wound is closer immediately after amputation (instead healing secondarily)

Procedure: Wound closure

Open wound

NO INTERVENTION

Wound is left to heal secondarily

Interventions

Wound closurePROCEDURE

Wound is closed or left open to heal secondarily after amputation.

Closed wound

Eligibility Criteria

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

You may qualify if:

  • Toe amputation due to diabetic foot infection

You may not qualify if:

  • Deep foot infection
  • Sepsis
  • No clinical infection (amputation due to trauma, deformity or uninfected necrosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Diabetic FootInfections

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Miska Vuorlaakso, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miska Vuorlaakso, PhD

CONTACT

+3583311611miska.vuorlaakso@gmail.com

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
Principal Investigator

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 12, 2023

Study Start

May 22, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

FI(1)