Trauma PatientsNCT06787495
Limb Salvage in Peripheral Arterial Trauma Patients
An observational study of Trauma Patients, run by Mekhael Rezk Abd-Elmalak at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma Patients
- What is being tested?
- Arterial repair
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital
Who may be able to join
- peripheral arterial trauma patients
Who cannot join
- trauma patients with vascular injuries other than peripheral arteries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Limb Loss in Peripheral Arterial Trauma Patients
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.
Read the detailed description
Trauma to the vascular system can be devastating. Peripheral arterial traumatic injuries rarely occur in isolation, often complicated by bone fractures and nerve injuries. As a result of these complex injury patterns, vascular extremity trauma presents unique challenges to injury management and is associated with significant morbidity.
In all trauma- related injuries , trauma is now the third leading cause of death and number one cause of death in people between the ages of 1 and 44 years . Vascular injuries comprise 3% of all civilian trauma and have significant potential morbidity. Leg trauma is common. However, it is associated with a significant vascular injury.The high energy of crushing trauma can cause extensive tissue damage with detrimental outcome such as high morbidity and mortality.[3] Management of associated life-threatening injuries takes priority which might lead to delay in definitive vascular repairs with subsequent limb loss.The most important risk factor for early limb loss is failed revascularization which is time dependent
- Conditions
- Trauma Patients
- Being tested
- Arterial repair
- Keywords
- Trauma patients with peripheral arterial trauma patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial repairProcedure or surgery
Arterial repair starting from simple repair or vein graft or synthetic graft
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From January 2021 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Sep 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trauma PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mekhael Rezk Abd-Elmalak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mekhael Rezk Abd-Elmalak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787495
- Sponsor's protocol ID
- Arterial trauma patients
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McAndrew MP, Lantz BA. Initial care of massively traumatized lower extremities. Clin Orthop Relat Res. 1989 Jun;(243):20-9.
PubMed 2721064Bondurant 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.
PubMed 3137367Mullenix 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.
PubMed 16828431Howe 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.
PubMed 3579025
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Limb Loss in Peripheral Arterial Trauma Patients
- ClinicalTrials.gov ID
- NCT06787495
- Acronym / sponsor ID
- Arterial trauma patients
- Conditions
- Trauma Patients
- Keywords
- Trauma patients with peripheral arterial trauma patients
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mekhael Rezk Abd-ElmalakUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trauma to the vascular system can be devastating. Peripheral arterial traumatic injuries rarely occur in isolation, often complicated by bone fractures and nerve injuries. As a result of these complex injury patterns, vascular extremity trauma presents unique challenges to injury management and is associated with significant morbidity.
In all trauma- related injuries , trauma is now the third leading cause of death and number one cause of death in people between the ages of 1 and 44 years . Vascular injuries comprise 3% of all civilian trauma and have significant potential morbidity. Leg trauma is common. However, it is associated with a significant vascular injury.The high energy of crushing trauma can cause extensive tissue damage with detrimental outcome such as high morbidity and mortality.[3] Management of associated life-threatening injuries takes priority which might lead to delay in definitive vascular repairs with subsequent limb loss.The most important risk factor for early limb loss is failed revascularization which is time dependent
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital
Key inclusion criteria (1 listed)
- peripheral arterial trauma patients
Key exclusion criteria (1 listed)
- trauma patients with vascular injuries other than peripheral arteries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial repairArterial repair starting from simple repair or vein graft or synthetic graft | Procedure or surgery | – |
Primary outcome
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.
Time frame: From January 2021 to December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 2721064McAndrew MP, Lantz BA. Initial care of massively traumatized lower extremities. Clin Orthop Relat Res. 1989 Jun;(243):20-9.
- Background: PubMed 3137367Bondurant 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.
- Background: PubMed 16828431Mullenix 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.
- Background: PubMed 3579025Howe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Patients, run by Mekhael Rezk Abd-Elmalak at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From January 2021 to December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787495, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.