136 Participants Needed

Surgical Debridement for Venous Leg Ulcers

AE
Overseen ByAliette Espinosa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who require long-term systemic corticosteroids or immunosuppressive therapy, or have used them in the 4 weeks prior to the study.

Is surgical debridement generally safe for humans?

Surgical debridement is considered safe when the wound is properly prepared, meaning it has good blood flow, the right antibiotics are used, and other health issues are managed. Enzymatic debridement, a related method, is safe even in wounds with high bacteria levels if used with topical antimicrobials.12345

How is the treatment Wound Edge Debridement unique for venous leg ulcers?

Wound Edge Debridement is unique because it involves the physical removal of dead or infected tissue to promote healing, which can be done through various methods like surgical, mechanical, or enzymatic techniques. This treatment is essential for improving blood flow and reducing infection risk, making it different from other treatments that might focus solely on managing symptoms or underlying causes.678910

What data supports the effectiveness of the treatment for venous leg ulcers?

Debridement, which involves removing dead or infected tissue, is essential for wound healing as it improves blood flow, reduces inflammation, and lowers infection risk. Various debridement techniques, including surgical and enzymatic methods, have been shown to aid in the healing of leg ulcers by preparing the wound bed and promoting tissue regeneration.468911

Who Is on the Research Team?

MT

Marjana Tomic-Canic, PhD

Principal Investigator

University of Miami

RK

Robert Kirsner, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My tests show I have vein problems, or I have at least 2 symptoms like varicose veins or swelling.
I have a vein-related sore on my leg between my knee and ankle.
My wound has yellow/white slough or non-viable tissue.
See 3 more

Exclusion Criteria

You are expected to live less than 6 months.
I cannot tolerate weekly compression therapy.
I have hepatitis.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive wound edge debridement in addition to standard of care treatment or only standard care treatment

4 weeks
Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Wound Edge Debridement
Trial Overview 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.
How Is the Trial Designed?
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.

Wound Edge Debridement is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Wound Debridement for:
  • Venous Leg Ulcers
  • Diabetic Foot Ulcers
  • Pressure Ulcers
  • Chronic Wounds
🇺🇸
Approved in United States as Wound Debridement for:
  • Venous Leg Ulcers
  • Diabetic Foot Ulcers
  • Pressure Ulcers
  • Chronic Wounds
🇨🇦
Approved in Canada as Wound Debridement for:
  • Venous Leg Ulcers
  • Diabetic Foot Ulcers
  • Pressure Ulcers
  • Chronic Wounds

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

Published Research Related to This Trial

Effective wound healing requires the removal of dead tissue and maintaining a moist environment, which can be achieved through surgical or non-surgical methods.
Biosurgical approaches, such as using maggots for debridement, are gaining popularity, while chronic venous leg ulcers need to be treated with compression therapy and vein surgery for optimal results.
[Wound debridement and treatment of ulcus cruris. Conservative and operative therapeutic procedures].Stege, H., Mang, R.[2018]
A new method for collecting debridement material from venous leg ulcers allows for the analysis of wound bed biomarkers, which can help in developing prognostic tests for treatment effectiveness.
The study found that inflammatory mediators, particularly CXCL8, were more prevalent in the wound environment, suggesting that targeting these factors could enhance healing by promoting fibroblast migration and the secretion of healing mediators.
Simple wound exudate collection method identifies bioactive cytokines and chemokines in (arterio) venous ulcers.Kroeze, KL., Vink, L., de Boer, EM., et al.[2015]
Surgical and hydrosurgical debridement techniques were found to be effective for treating leg ulcers, with conventional surgical debridement showing a significantly greater reduction in wound size and higher healing rates.
Among alternative methods, manuka honey demonstrated a significant reduction in wound surface area compared to standard treatments, while other techniques like autolytic and enzymatic debridement showed varying effectiveness, indicating the need for further research to confirm their impacts.
Impact on wound healing and efficacy of various leg ulcer debridement techniques.Doerler, M., Reich-Schupke, S., Altmeyer, P., et al.[2012]

Citations

[Wound debridement and treatment of ulcus cruris. Conservative and operative therapeutic procedures]. [2018]
Simple wound exudate collection method identifies bioactive cytokines and chemokines in (arterio) venous ulcers. [2015]
Impact on wound healing and efficacy of various leg ulcer debridement techniques. [2012]
Wound debridement products and techniques: clinical examples and literature review. [2022]
[Current methods for wound debridement]. [2011]
Enzymatic debriding agents are safe in wounds with high bacterial bioburdens and stimulate healing. [2021]
The role of debridement in wound bed preparation in chronic wound: A narrative review. [2022]
Readers' Questions. [2019]
Surgical débridement. The key to successful wound healing and reconstruction. [2019]
Management of pain associated with debridement of leg ulcers: a randomized, multicentre, pilot study comparing nitrous oxide-oxygen mixture inhalation and lidocaïne-prilocaïne cream. [2013]
[The role of hydrocolloid dressings in the process of debridement and treatment of venous leg ulcers]. [2006]
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