NCT04694053

Brief Summary

A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 4, 2020

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

6 days

First QC Date

December 29, 2020

Last Update Submit

December 31, 2020

Conditions

Fournier Gangrene

Keywords

Fournier's gangreneType 2 diabetessurgical debridement

Outcome Measures

Primary Outcomes (2)

  • Number of Participants

    Number of patients enrolled by the emergency room.

    From 3 November 2020 at 23 November 2020

  • Fournier's gangrene evolution after treatment

    Evolution of gangrene after surgical debridement of perineal and perianal regions.

    20 days

Interventions

surgical debridementPROCEDURE

The surgical team performed an extended surgical debridement to healthy tissue of external genital, as well as perineal, perianal, and infrapubic regions.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

You may qualify if:

  • Clinical diagnosis of Fournier's Gangrene Insulin dependent diabetes (type 2)

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catania

Catania, 95123, Italy

Location

MeSH Terms

Conditions

Fournier GangreneDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Daniele o Provenzano, md

    https://www.unict.it/

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2020

First Posted

January 5, 2021

Study Start

November 4, 2020

Primary Completion

November 10, 2020

Study Completion

December 1, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)