NCT02440282

Brief Summary

Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

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

January 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

2.3 years

First QC Date

April 24, 2015

Last Update Submit

July 1, 2015

Conditions

Diabetic Foot UlcerLower Extremity Amputation

Keywords

patients

Outcome Measures

Primary Outcomes (4)

  • Mean blood pressure

    every ten minutes from preinduction to 30minutes after sugery

  • Mean blood pressure

    from arrival at recovery room until 20miutes after surgery at recovery room

  • Heart rate

    every ten minutes from preinduction to 30minutes after sugery

  • Heart rate

    from arrival at recovery room until 20miutes after surgery at recovery room

Study Arms (3)

Group A

patients undergo general anesthesia

Group B

spinal anesthesia

Group C

ultrasound-guided sciatic nerve block

Eligibility Criteria

Age29 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive 86 diabetic foot patients who underwent minor LEA

You may qualify if:

  • diabetic foot patients who underwent minor LEA

You may not qualify if:

  • emergency cases
  • patients who underwent major upper or lower extremity amputations
  • patients who received general anesthesia following fail regional or spinal anesthesia
  • patients who underwent LEA within 1year, and patients who underwent other concomitant surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 12, 2015

Study Start

January 1, 2012

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

July 2, 2015

Record last verified: 2015-07