Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.

August 29, 2024 updated by: Islam Marghny Hassan, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients developing peripheral vascular complications due to IVDA

Description

Inclusion Criteria:

  • Current IV drug abuser
  • (Age from 18 to 80 )
  • Presented with peripheral vascular complications (pseudoaneurysm, limb ischemia, venous thrombosis, skin infection.)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mostafa S Khalil, Professor, Assiut University
  • Study Director: Ashraf G Taha, Assist. prof, Assiut University
  • Study Director: Mohamed S Abdelkareem, Lecturer, Assiut University
  • Principal Investigator: Islam M Hassan, Resident, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 29, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IVDA Complications

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe