NCT03871049

Brief Summary

effect of intrathecal dexamethasone on blood sugar of dietetic patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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

First Submitted

Initial submission to the registry

March 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2021

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

March 10, 2019

Last Update Submit

February 9, 2022

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • blood sugar

    24 hours

Study Arms (2)

group 1

PLACEBO COMPARATOR

intathecal bupivacaine

Drug: Bupivacaine

group 2

ACTIVE COMPARATOR

intrathecal bupivacaine with dexamethasone

Drug: Bupivacaine with dexamethasone

Interventions

Bupivacaine with dexamethasoneDRUG

bupivacaine with dexamethasone

group 2
BupivacaineDRUG

bupivacaine

group 1

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • control diabetic patients will undergo foot surgeries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

BupivacaineDexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant profesor

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 12, 2019

Study Start

January 10, 2020

Primary Completion

July 12, 2021

Study Completion

September 17, 2021

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

EG(1)