IVDANCT06579638
Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.
An observational study of IVDA, run by Assiut University.
Trial summary
Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- IVDA
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients developing peripheral vascular complications due to IVDA
Who may be able to join
- Current IV drug abuser
- (Age from 18 to 80 )
- Presented with peripheral vascular complications (pseudoaneurysm, limb ischemia, venous thrombosis, skin infection.)
Who cannot join
- Drug intake other than IV
- ( less than 18 or more than 80 )
- Presented with overdose
- Malignancy or serious illness
- Causes of vascular complications other than IV drug abuse
Trial locations and contacts
No sites are listed yet.
About this study
Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.
Read the detailed description
Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.The prevalence of injected drug use is estimated between 0.09% and 1.3% depending on geographic location. There are various complications of IV drug abuse that are related to the toxicity of the substance, mode of consumption, and drug taking mode. These complications include skin and soft tissue infection (cellulitis, abscess, necrotizing fasciitis) (28%),infected(ranges from .03% to 1%)or non-infected pseudoaneurysm ,arterial ischemia( thrombosis , distal embolization), and venous thrombosis(29%).
The wide spectrum of complications due to IVDA mandates a wide range of treatment for each type starting from simple medical treatment such as antibiotics or anticoagulation to the most extensive surgical treatment options in cases such as PA that may require ligation of the arterial supply without revascularization. This may lead to gravid complications such as limb amputation.
- Conditions
- IVDA
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns and outcomes of IVDA
To describe the patterns, methods of treatment and outcomes of self-injection of addictive drugs such as amputation rate and patency rate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IVDAStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Marghny Hassan, Assiut University
- Investigators
- Mostafa S Khalil, Professor, Study chair, Assiut UniversityAshraf G Taha, Assist. prof, Study director, Assiut UniversityMohamed S Abdelkareem, Lecturer, Study director, Assiut UniversityIslam M Hassan, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579638
- Sponsor's protocol ID
- IVDA Complications
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsao JW, Marder SR, Goldstone J, Bloom AI. Presentation, diagnosis, and management of arterial mycotic pseudoaneurysms in injection drug users. Ann Vasc Surg. 2002 Sep;16(5):652-62. doi: 10.1007/s10016-001-0124-6. Epub 2002 Sep 4.
PubMed 12203000Senbanjo R, Strang J. Evaluation of Femoral Ultrasonography as a Tool for Promoting Cessation of Groin-Injecting Behaviour. Eur Addict Res. 2015;21(4):204-10. doi: 10.1159/000375260. Epub 2015 Apr 21.
PubMed 25896872Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23.
PubMed 29074409
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.
- ClinicalTrials.gov ID
- NCT06579638
- Acronym / sponsor ID
- IVDA Complications
- Conditions
- IVDA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 30 Aug 2024 (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.
Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.
Detailed description
Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.The prevalence of injected drug use is estimated between 0.09% and 1.3% depending on geographic location. There are various complications of IV drug abuse that are related to the toxicity of the substance, mode of consumption, and drug taking mode. These complications include skin and soft tissue infection (cellulitis, abscess, necrotizing fasciitis) (28%),infected(ranges from .03% to 1%)or non-infected pseudoaneurysm ,arterial ischemia( thrombosis , distal embolization), and venous thrombosis(29%).
The wide spectrum of complications due to IVDA mandates a wide range of treatment for each type starting from simple medical treatment such as antibiotics or anticoagulation to the most extensive surgical treatment options in cases such as PA that may require ligation of the arterial supply without revascularization. This may lead to gravid complications such as limb amputation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients developing peripheral vascular complications due to IVDA
Key inclusion criteria (3 listed)
- Current IV drug abuser
- (Age from 18 to 80 )
- Presented with peripheral vascular complications (pseudoaneurysm, limb ischemia, venous thrombosis, skin infection.)
Key exclusion criteria (5 listed)
- Drug intake other than IV
- ( less than 18 or more than 80 )
- Presented with overdose
- Malignancy or serious illness
- Causes of vascular complications other than IV drug abuse
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
Patterns and outcomes of IVDA
Time frame: 1 year
To describe the patterns, methods of treatment and outcomes of self-injection of addictive drugs such as amputation rate and patency rate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Results publication: PubMed 12203000Tsao JW, Marder SR, Goldstone J, Bloom AI. Presentation, diagnosis, and management of arterial mycotic pseudoaneurysms in injection drug users. Ann Vasc Surg. 2002 Sep;16(5):652-62. doi: 10.1007/s10016-001-0124-6. Epub 2002 Sep 4.
- Results publication: PubMed 25896872Senbanjo R, Strang J. Evaluation of Femoral Ultrasonography as a Tool for Promoting Cessation of Groin-Injecting Behaviour. Eur Addict Res. 2015;21(4):204-10. doi: 10.1159/000375260. Epub 2015 Apr 21.
- Results publication: PubMed 29074409Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23.
- Individual participant dataSharing planned: No
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.
Mostafa S Khalil, Professor study chair
Assiut University
Ashraf G Taha, Assist. prof study director
Assiut University
Mohamed S Abdelkareem, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of IVDA, run by Assiut University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Islam M Hassan, Resident (+2001285007001, eslammarghny22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns and outcomes of IVDA (time frame: 1 year). 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 NCT06579638, which also lists 3 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 30 Aug 2024.