Toe Amputations in Patients With Diabetes | NCT05855980

Studies
Toe Amputations in Patients With Diabetes

NCT05855980

Sponsor

Tampere University Hospital

Status

Unknown status

Last Update Posted

Dec 12, 2023Actual

Enrollment

102Estimated

Phase

Not Applicable

Conditions

Diabetic Foot
Infections
Amputation

Interventions

Wound closure

Countries

Finland

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2023Actual

Primary Completion Date

May 1, 2025Estimated

Completion Date

May 1, 2025Estimated

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

May 3, 2023

First Posted Date

May 12, 2023Actual

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

Dec 5, 2023

Last Update Posted Date

Dec 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Miska Vuorlaakso, Principal Investigator, Tampere University HospitalPrincipal Investigator

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients with diabetes undergoing toe amputation due to infection, are recruited for this study. Based on randomization, wound is either closed or left open during the amputation procedure. If primary closure is not possible (e.g. deep abscess) and patient is randomized to closed group, delayed closure is performed when feasible. Patients are followed up in outpatient clinic 3 month after amputation. Primary outcome is wound healing that is evaluated during follow ups in the outpatient clinic. Functional outcome is evaluated with PROM questionnaires preoperatively and during the follow up.

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

102Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Wound closure	Procedure	Wound is closed or left open to heal secondarily after amputation.	Closed wound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound healed	Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit	3 months

Secondary Outcomes

Measure	Description	Time Frame
Complications	Percentage of patients experiencing complication during 3 month follow-up	3 months
Functional outcome: 15D	15D quality of life questionnaire 3 months after amputation and change compared to preoperative 15D score. 15D is 15 dimensional questionnaire that provides score between 0 and 1 representing health related quality of life (HRQOL). Higher value represents better HRQOL.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Toe amputation due to diabetic foot infection

Exclusion Criteria:

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

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

Name	Role	Phone	Extension	Email
Miska Vuorlaakso, PhD	Contact	+3583311611		miska.vuorlaakso@gmail.com

Overall Officials

Name	Affiliation	Role
Miska Vuorlaakso, PhD	Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital	Recruiting	Tampere			Finland

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot
D007239	Infections

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided