NCT06787495

Brief Summary

The aim of this study is to determine risk factors associated with failure of limb salvage in patients with periphral arterial injuries with or without attempts of revascularization.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 1, 2021

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

January 11, 2025

Last Update Submit

January 15, 2025

Conditions

Trauma Patients

Keywords

Trauma patients with peripheral arterial trauma patients

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be : technical success of the surgical intervention to control the bleeding and maintain vascularity of the affected limb (2) predictors of limb salvage.

    From January 2021 to December 2025

Interventions

Arterial repairPROCEDURE

Arterial repair starting from simple repair or vein graft or synthetic graft

Eligibility Criteria

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

Hospital

You may qualify if:

  • peripheral arterial trauma patients

You may not qualify if:

  • trauma patients with vascular injuries other than peripheral arteries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

Related Publications (4)

  • McAndrew MP, Lantz BA. Initial care of massively traumatized lower extremities. Clin Orthop Relat Res. 1989 Jun;(243):20-9.

    PMID: 2721064BACKGROUND

  • Bondurant FJ, Cotler HB, Buckle R, Miller-Crotchett P, Browner BD. The medical and economic impact of severely injured lower extremities. J Trauma. 1988 Aug;28(8):1270-3. doi: 10.1097/00005373-198808000-00023.

    PMID: 3137367BACKGROUND

  • Mullenix PS, Steele SR, Andersen CA, Starnes BW, Salim A, Martin MJ. Limb salvage and outcomes among patients with traumatic popliteal vascular injury: an analysis of the National Trauma Data Bank. J Vasc Surg. 2006 Jul;44(1):94-100. doi: 10.1016/j.jvs.2006.02.052.

    PMID: 16828431BACKGROUND

  • Howe HR Jr, Poole GV Jr, Hansen KJ, Clark T, Plonk GW, Koman LA, Pennell TC. Salvage of lower extremities following combined orthopedic and vascular trauma. A predictive salvage index. Am Surg. 1987 Apr;53(4):205-8.

    PMID: 3579025BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mekhael Rezk Abd-Elmalak Mesael

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 22, 2025

Study Start

September 1, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations

EG(1)