AmputationEVAC-PTSD StudNCT07502313
Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation
An observational study of Amputation and PTSD, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
Trial summary
This study aims to evaluate the relationship between evacuation time, tourniquet use, and the development of post-traumatic stress disorder (PTSD) in patients with combat-related amputations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Amputation, PTSD, Combat Posttraumatic Stess Disorder
- How many people
- 300 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Mar 2026to 15 Nov 2026
- How long will I take part?
- 6 Months
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of Ukrainian military veterans who sustained combat-related traumatic injuries resulting in a single-limb amputation. Participants are recruited from rehabilitation centres within the Superhumans Center network (Lviv, Dnipro, and Odesa, Ukraine). Eligible participants are adults (≥18 years) who were injured after February 2022 and are admitted to rehabilitation within 2-4 months following injury. The study focuses on individuals with no prior history of post-traumatic stress disorder (PTSD) to allow assessment of incident PTSD related to the current trauma. This population represents patients exposed to high-energy combat injuries, often associated with prolonged evacuation times and the use of hemostatic tourniquets. The cohort is therefore particularly relevant for investigating the relationship between prehospital factors and long-term psychological outcomes. Participants are followed prospectively for 18 months with repeated psychological assessment
Who may be able to join
- Ukrainian veterans with combat-related injury (post-February 2022)
- Single limb amputation
- Admission to rehabilitation within 2-4 months post-injury
- Age ≥18 years
- Ability to provide informed consent
Who cannot join
- Prior PTSD diagnosis before current injury
- Multiple amputations
- Rehabilitation duration >3 months
- Return to active military duty before follow-up completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation: A Prospective Cohort Study
This study aims to evaluate the relationship between evacuation time, tourniquet use, and the development of post-traumatic stress disorder (PTSD) in patients with combat-related amputations. In the context of modern warfare, prolonged evacuation times and extended tourniquet application may contribute not only to physical injury but also to psychological trauma. The study will prospectively follow patients over 18 months to identify key predictors of PTSD and to assess their interaction.
Read the detailed description
Combat-related amputations are frequently associated with prolonged evacuation times and the use of hemostatic tourniquets. While these factors are critical for survival, their potential contribution to long-term psychological outcomes remains insufficiently studied.
This prospective longitudinal study will investigate how evacuation delays and tourniquet duration influence the development of PTSD symptoms in Ukrainian veterans with limb amputations. The study will also evaluate the interaction between these factors and their cumulative psychological impact.
Participants will be followed for 18 months using validated PTSD screening tools, including the PCL-5 questionnaire, combined with retrospective analysis of medical records.
- Conditions
- Amputation, PTSD, Combat Posttraumatic Stess Disorder, Combat Trauma
- Keywords
- Post-Traumatic Stress Disorder, Combat Trauma, Amputation, Tourniquet Use, Evacuation Time
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Combat-Related Amputation Cohort | Participants in this cohort are Ukrainian veterans with combat-related single-limb amputations who are undergoing rehabilitation within the Superhumans Center network. All participants are enrolled within 2-4 months following injury and are followed prospectively for 18 months. This is an observational study with no interventional treatment assigned. The primary exposures of interest are evacuation time and duration of tourniquet use, obtained from medical records. Participants undergo structured psychological assessment using validated instruments, including the PTSD Checklist for DSM-5 (PCL-5), at predefined time points during rehabilitation and follow-up. The study aims to evaluate the association between these exposure variables and the development and progression of post-traumatic stress disorder (PTSD), as well as to assess their combined and interaction effects on psychological outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD severity measured by PCL-5 score
Severity of post-traumatic stress disorder (PTSD) symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5), a validated 20-item self-report questionnaire. Each item is scored on a scale from 0 (not at all) to 4 (extremely), with a total score range of 0 to 80, where higher scores indicate greater symptom severity.
The primary outcome will be the total PCL-5 score measured longitudinally to evaluate changes in PTSD symptom severity over time and its association with evacuation time and duration of tourniquet use.
Measured: 18 months (baseline, 2, 6, 12, and 18 months follow-up)
Secondary outcomes (1)
Change in PTSD Severity Over Time
Change in PTSD symptom severity measured as the difference in total PCL-5 score between baseline and follow-up assessments. This outcome will evaluate the trajectory of PTSD symptoms over time.
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502313
- Sponsor's protocol ID
- 1303v04032026
- Other IDs
- Superhumans war trauma center
- Acronym
- EVAC-PTSD Stud
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be publicly shared due to the sensitive nature of the study population, which includes military veterans with combat-related injuries and psychological outcomes. Although all data will be de-identified prior to analysis, there remains a potential risk of re-identification. Data may be made available upon reasonable request to the principal investigator for scientifically valid research purposes, subject to approval by the institutional ethics committee and in accordance with applicable data protection regulations.
Publications
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PubMed 26606250
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07502313
- Acronym / sponsor ID
- EVAC-PTSD Stud / 1303v04032026
- Conditions
- Amputation, PTSD, Combat Posttraumatic Stess Disorder, Combat Trauma
- Keywords
- Post-Traumatic Stress Disorder, Combat Trauma, Amputation, Tourniquet Use, Evacuation Time
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)University, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 30 Mar 2026 (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.
This study aims to evaluate the relationship between evacuation time, tourniquet use, and the development of post-traumatic stress disorder (PTSD) in patients with combat-related amputations. In the context of modern warfare, prolonged evacuation times and extended tourniquet application may contribute not only to physical injury but also to psychological trauma. The study will prospectively follow patients over 18 months to identify key predictors of PTSD and to assess their interaction.
Detailed description
Combat-related amputations are frequently associated with prolonged evacuation times and the use of hemostatic tourniquets. While these factors are critical for survival, their potential contribution to long-term psychological outcomes remains insufficiently studied.
This prospective longitudinal study will investigate how evacuation delays and tourniquet duration influence the development of PTSD symptoms in Ukrainian veterans with limb amputations. The study will also evaluate the interaction between these factors and their cumulative psychological impact.
Participants will be followed for 18 months using validated PTSD screening tools, including the PCL-5 questionnaire, combined with retrospective analysis of medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combat-Related Amputation Cohort | – | –Participants in this cohort are Ukrainian veterans with combat-related single-limb amputations who are undergoing rehabilitation within the Superhumans Center network. All participants are enrolled within 2-4 months following injury and are followed prospectively for 18 months. This is an observational study with no interventional treatment assigned. The primary exposures of interest are evacuation time and duration of tourniquet use, obtained from medical records. Participants undergo structured psychological assessment using validated instruments, including the PTSD Checklist for DSM-5 (PCL-5), at predefined time points during rehabilitation and follow-up. The study aims to evaluate the association between these exposure variables and the development and progression of post-traumatic stress disorder (PTSD), as well as to assess their combined and interaction effects on psychological outcomes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of Ukrainian military veterans who sustained combat-related traumatic injuries resulting in a single-limb amputation. Participants are recruited from rehabilitation centres within the Superhumans Center network (Lviv, Dnipro, and Odesa, Ukraine). Eligible participants are adults (≥18 years) who were injured after February 2022 and are admitted to rehabilitation within 2-4 months following injury. The study focuses on individuals with no prior history of post-traumatic stress disorder (PTSD) to allow assessment of incident PTSD related to the current trauma. This population represents patients exposed to high-energy combat injuries, often associated with prolonged evacuation times and the use of hemostatic tourniquets. The cohort is therefore particularly relevant for investigating the relationship between prehospital factors and long-term psychological outcomes. Participants are followed prospectively for 18 months with repeated psychological assessment
Key inclusion criteria (5 listed)
- Ukrainian veterans with combat-related injury (post-February 2022)
- Single limb amputation
- Admission to rehabilitation within 2-4 months post-injury
- Age ≥18 years
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Prior PTSD diagnosis before current injury
- Multiple amputations
- Rehabilitation duration >3 months
- Return to active military duty before follow-up completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PTSD severity measured by PCL-5 score
Time frame: 18 months (baseline, 2, 6, 12, and 18 months follow-up)
Severity of post-traumatic stress disorder (PTSD) symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5), a validated 20-item self-report questionnaire. Each item is scored on a scale from 0 (not at all) to 4 (extremely), with a total score range of 0 to 80, where higher scores indicate greater symptom severity. The primary outcome will be the total PCL-5 score measured longitudinally to evaluate changes in PTSD symptom severity over time and its association with evacuation time and duration of tourniquet use.
1 secondary outcome
Change in PTSD Severity Over Time
Time frame: Baseline to 18 months
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 3 Apr 2026.
- Results publication: PubMed 26606250Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be publicly shared due to the sensitive nature of the study population, which includes military veterans with combat-related injuries and psychological outcomes. Although all data will be de-identified prior to analysis, there remains a potential risk of re-identification. Data may be made available upon reasonable request to the principal investigator for scientifically valid research purposes, subject to approval by the institutional ethics committee and in accordance with applicable data protection regulations.
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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.
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 Amputation and PTSD, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Apr 2026. 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 Ukraine. 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?
Contact Dmytro Dmytriiev, PhD.Professor (+380674309449, d.dmytriiev@superhumans.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD severity measured by PCL-5 score (time frame: 18 months (baseline, 2, 6, 12, and 18 months follow-up)). 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 NCT07502313, which also lists 1 linked publication.
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 3 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.