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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals who have a graft-ready venous leg ulcer of at least 3 months duration, which has not responded to standard conventional therapy
Individuals who have venous incompetency as defined by > 1.0 seconds in vein segments on standing reflux exam by duplex or an abnormal venous refill time of < 21 seconds by PPG or > 2 cc per second by APG. Duplex or PPG/APG will be used to establish venous insufficiency. Doppler will be utilized to rule out arterial disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new treatment for venous leg ulcers, comparing it to a placebo and standard treatment.
Who is the study for?
This trial is for adults with non-healing venous leg ulcers present for at least 3 months, sized 2-20 cm². Participants must have venous incompetency confirmed by specific tests and an Ankle Brachial Pressure Index of ≥0.8. Excluded are those under 18, pregnant or lactating women, individuals with significant lab abnormalities, chronic renal insufficiency, recent use of certain medications including immunosuppressants and corticosteroids, infections in the wound area, uncontrolled diabetes or other conditions affecting wound healing.Check my eligibility
What is being tested?
The study aims to compare three approaches: ICXP007 with compression bandaging versus placebo with compression bandaging versus compression bandaging alone on non-infected venous leg ulcers to see which is most effective in promoting healing.See study design
What are the potential side effects?
Potential side effects may include local reactions at the treatment site such as redness or irritation. Since ICXP007 is a new treatment being tested, there could be unknown risks that will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a leg ulcer for over 3 months that hasn't healed with standard treatments.
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I have been diagnosed with venous insufficiency based on specific tests.
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I can walk on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.
Secondary outcome measures
Appearance of new ulcer in the target wound area post closure.
Incidence of closure at 16, 20 and 24 weeks.
Incidence of re-closure at 16, 20 and 24 weeks.
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Who is running the clinical trial?
IntercytexLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that would prevent wounds from healing properly.I haven't been treated for cancer, except skin cancer, in the last 3 months.I am allergic to Aprotinin or ingredients in Tisseel VH S/D.My hemoglobin or albumin levels are low and considered clinically significant.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I am using birth control.I am under 18 years old.My wound exposes bone, tendon, or fascia.I am currently being treated for a collagen vascular disease like rheumatoid arthritis.I have had signs of cellulitis or bone infection in the last month.My wound was infected but is now clear of ß-haemolytic streptococcus.I require dialysis for chronic kidney failure.I haven't taken steroids or immunosuppressants in the last 30/90 days.I have been diagnosed with venous insufficiency based on specific tests.I can walk on my own.I have a leg ulcer for over 3 months that hasn't healed with standard treatments.My wound is between 2 cm2 and 20 cm2 in size.I understand the study, can follow its procedures, and will attend all required visits.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medication able to be prescribed by certified doctors?
"The safety of this medical intervention falls on the third tier of our 1-3 scale because it is a Phase 3 trial. This means that, although there is some efficacy data, there are multiple rounds of data supporting safety."
Answered by AI
Are there any current vacancies for individuals in this experiment?
"No, this specific trial is not currently seeking participants. That being said, there are 354 other trials that are recruiting patients."
Answered by AI
How many different medical clinics in North America are running this study?
"Presently, there are 22 patients enrolled in this clinical trial at various locations including St Michael's Hospital in Toronto, UNC Wound Care Clinic in Chapel Hill, and Doctor's Research Network in Miami."
Answered by AI
Who else is applying?
What site did they apply to?
HOPE Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
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