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Procedure

Surgical Debridement for Venous Leg Ulcers

N/A
Recruiting
Led By Marjana Tomic-Canic, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Conformation of venous disease by non-invasive venous studies with either Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trial will use genomic profiling and candidate genes and proteins to develop a more effective surgical debridement for chronic non-healing venous leg ulcers, with the goal of improving healing.

Who is the study for?
Adults over 18 with chronic venous leg ulcers between the knee and ankle, larger than 5cm2, lasting at least 6 months can join. They must have signs of venous disease but no severe health issues like active cancer, uncontrolled diabetes, recent biologic therapy for ulcers, or allergies to certain anesthetics.Check my eligibility
What is being tested?
The study is testing a new surgical debridement strategy guided by genetic profiling against standard care for healing chronic non-healing venous leg ulcers. The effectiveness of this tailored approach will be evaluated.See study design
What are the potential side effects?
While specific side effects are not listed here, surgical debridement may include risks such as pain at the wound site, infection risk increase due to open wounds and potential bleeding during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My tests show I have vein problems, or I have at least 2 symptoms like varicose veins or swelling.
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I have a vein-related sore on my leg between my knee and ankle.
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My wound has yellow/white slough or non-viable tissue.
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My wound is larger than 5cm2 and does not show tendon, muscle, or bone.
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My wound has been present for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the genetic profile after debridement in the intervention group.
Secondary outcome measures
Percent rate of healing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Wound Edge Debridement GroupExperimental Treatment2 Interventions
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Group II: Standard care groupActive Control1 Intervention
Participants in this group will receive only the standard care of treatment for up to 4 weeks.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
408,899 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,579 Total Patients Enrolled
Marjana Tomic-Canic, PhDPrincipal InvestigatorUniversity of Miami

Media Library

Wound Edge Debridement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03796793 — N/A
Venous Leg Ulcer Research Study Groups: Wound Edge Debridement Group, Standard care group
Venous Leg Ulcer Clinical Trial 2023: Wound Edge Debridement Highlights & Side Effects. Trial Name: NCT03796793 — N/A
Wound Edge Debridement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03796793 — N/A

Frequently Asked Questions

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

How many participants are eligible for this clinical trial?

"Correct. Information on clinicaltrials.gov attests that this medical trial is actively recruiting patients, having been originally posted on March 18th 2019 and edited most recently on May 6th 2022. In total, 360 participants are required from a single research site."

Answered by AI

Is enrollment for this trial available to individuals at the present time?

"Affirmative, clinicaltrials.gov highlights that this study is open to participants and has been since March 18th 2019 with the last edit occuring on May 6th 2022. 360 individuals are required for enrolment at one site."

Answered by AI
~47 spots leftby Dec 2024