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Interrogation Arm for Venous Leg Ulcer (IGuideU Trial)

N/A
Waitlist Available
Led By Stephen Black, MD
Research Sponsored by Philips Clinical & Medical Affairs Global
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3,6,12,18, and 24 months
Awards & highlights

IGuideU Trial Summary

This trial will test whether IVUS can improve accuracy of diagnosis and guide treatment for venous leg ulcers, with the hope of reducing cost of care.

Eligible Conditions
  • Venous Leg Ulcer

IGuideU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3,6,12,18, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3,6,12,18, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of the difference in deep venous obstruction (DVO) detection and the subsequent changes in treatment plan informed by IVUS compared to MPV.
Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group
Secondary outcome measures
Change in Quality of Life scores using the 36 Item Short Form question assessment as compared in both arms
Change in Quality of Life scores using the EQ5D-5L as compared in both arms
Change in clinical classification using the Clinical Etiology and Anatomy Pathology classification system
+6 more

IGuideU Trial Design

2Treatment groups
Experimental Treatment
Group I: Interrogation ArmExperimental Treatment1 Intervention
patients will first be evaluated with MPV (limited to 3 views). The prescribed course of treatment based on the MPV results will be documented and patients will then be evaluated using IVUS. A treatment plan based on IVUS results will be compared with the MPV guided treatment plan and any differences will be documented. Any patients determined to still require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement.
Group II: Deferred Interrogation ArmExperimental Treatment1 Intervention
Deferred Interrogation Guidelines for this study are as follows: Mandate: • Continued compression therapy/stockings as prescribed. Allow: Periodic leg elevation. Sclerotherapy under ulcer bed. Recommend mechanical debridement as needed. Wound biopsy if evidence of infection. Systemic antibiotics if patient is diagnosed with an infection, avoid prophylactic prescription. Pain management medication (Pentoxifylline/Trental) allowed but not recommended Topical antimicrobial as needed. Prohibit: Negative pressure systems. Artificial and/or autologous skin grafting within first 3 months after randomization and within the first 3 months for subjects that crossover from deferred interrogation to the interrogation arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVUS
2014
Completed Phase 3
~2420

Find a Location

Who is running the clinical trial?

Philips Clinical & Medical Affairs GlobalLead Sponsor
48 Previous Clinical Trials
15,966 Total Patients Enrolled
Stephen Black, MDPrincipal InvestigatorSt. Thomas and Guys Hospital
2 Previous Clinical Trials
560 Total Patients Enrolled
Paul Gagne, MDPrincipal InvestigatorVascular Care CT, PLLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there opportunity to join the investigation at this time?

"The current state of affairs on clinicaltrials.gov confirms that this medical research is actively seeking participants; it was first posted on October 12th 2021 and the last update occurred October 24th 2022."

Answered by AI

What are the chief goals of this investigation?

"Philips Clinical & Medical Affairs Global, the sponsor of this study, has specified that the primary outcome will be monitored throughout a 24 month period and is Rate of detection and difference in complete ulcer healing between the two groups. Additionally, secondary outcomes such as Rate of Ulcer Healing measured at intervals (3-24 months), Quality of Life scores utilizing EQ5D-5L (0-100 score with higher being better), and Venous Ulcer Assessment VCSS (0-30 scoring system with lower indicating improvement) are also to be assessed."

Answered by AI

Are there a range of healthcare facilities participating in this experiment within the city limits?

"Presently, this clinical trial is being administered in 8 different locations. This includes Charlotte, New york and Houma with other facilities dispersed over the nation. To reduce travel-related commitments, it is advisable to select a site close to you should you wish to take part."

Answered by AI

To what extent is the research team engaging with participants?

"Absolutely. Clinicaltrials.gov records suggest that the trial, which was first announced on December 10th 2021 and updated most recently October 24th 2022 is actively recruiting participants. To this end, 266 individuals need to be gathered from 8 distinct locations."

Answered by AI

Is it possible to enlist in this medical experiment?

"This medical study is searching for 266 participants with varicose ulcers aged between 18 and 85. Essential requirements include: the ability and intention to comply with the protocol outlined by signing an IRB/EC approved informed consent form, CEAP C6 active venous leg ulcer, palpable dorsalis pedis or posterior tibial artery (DP/PT) pulses at ipsilateral foot or ankle brachial index (ABI) ≥0.8, current VLU present ≤48 months, age between 18-85 years old have undergone prior treatment of clinically significant reflux in target limb at least 3 months before enrollment ("

Answered by AI

Does your research encompass individuals aged eighty-five or above?

"This clinical trial is seeking participants who are of mature age (18+) but who have yet to reach their twilight years (less than 85)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
2021. "Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04696354.
~3 spots leftby Apr 2025
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