Surgical Debridement for Venous Leg Ulcers

Overseen By Aliette Espinosa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Diabetes, Cancer, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to heal stubborn venous leg ulcers, which are wounds between the knee and ankle that resist healing. It compares regular wound care to wound edge debridement, a type of surgical debridement that cleans the wound's edges to improve healing. Individuals with a venous leg ulcer for at least six months who can wear a compression bandage might be suitable candidates. The goal is to determine if this new method can enhance healing for these difficult wounds. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could improve future treatment options for venous leg ulcers.

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.

What prior data suggests that this surgical debridement is safe for venous leg ulcers?

Research has shown that wound edge debridement is generally well-tolerated. This process involves removing dead tissue from a wound to aid healing. Studies have found that this method can improve healing in venous leg ulcers, which are long-lasting wounds on the legs.

Reports from various studies indicate that wound edge debridement effectively removes unhealthy tissue with few serious side effects. Most people undergoing this procedure experience only mild discomfort, and severe reactions are rare. For those considering joining a trial for this treatment, these findings suggest it is a safe option with a low risk of serious adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about wound edge debridement for venous leg ulcers because it offers a hands-on approach to cleaning up the wound edges, which might enhance healing. Unlike standard care options that often include compression therapy and dressings, this technique actively removes dead tissue from the wound edges. This can create a healthier environment for healing and may lead to faster recovery times. By combining this method with standard care, there's potential to significantly improve outcomes for patients with venous leg ulcers.

What evidence suggests that wound edge debridement is effective for venous leg ulcers?

Research has shown that cleaning the edges of a wound can aid in healing venous leg ulcers. One study found that using a mechanical method to clean wounds reduced bacteria by about 30%. Fewer bacteria can lead to better healing. While non-surgical methods haven't consistently sped up healing, surgical cleaning like wound edge debridement, which participants in this trial may receive, might be more effective. These findings suggest that this method could be a promising treatment for improving healing in chronic venous leg ulcers. ^{2 5 6 7 8}

Who Is on the Research Team?

Marjana Tomic-Canic, PhD

Principal Investigator

University of Miami

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.

Exclusion Criteria

You are expected to live less than 6 months.

I cannot tolerate weekly compression therapy.

I have hepatitis.

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?

Group I: Wound Edge Debridement Group Experimental Treatment 2 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 group Active Control 1 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

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

Debridement is crucial for effective wound healing as it removes harmful materials that can delay recovery, leading to improved microcirculation, reduced inflammation, and lower infection risks.

The choice of debridement technique should be tailored to individual factors such as the type and depth of the wound, presence of biofilm, and patient preferences, highlighting the importance of personalized treatment in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound debridement products and techniques: clinical examples and literature review. Nowak, M., Mehrholz, D., Barańska-Rybak, W., et al.[2022]

The use of appropriate wound dressings is crucial for effective healing and can significantly impact patient outcomes.

Sharp debridement, a method of removing dead or infected tissue, is an important procedure that can enhance the effectiveness of wound dressings and promote faster recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readers' Questions. [2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Wound debridement and treatment of ulcus cruris. Conservative and operative therapeutic procedures]. Stege, H., Mang, R.[2018]

Maggot debridement therapy has been consistently effective in treating chronic wounds, highlighting its potential as a reliable option for wound care.

Newer methods like hydro-surgery, low-frequency ultrasonic, and enzymatic collagenase debridement are gaining interest for their quicker and less painful application, but their safety and effectiveness still require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of debridement in wound bed preparation in chronic wound: A narrative review. Thomas, DC., Tsu, CL., Nain, RA., et al.[2022]

In a study involving 41 patients undergoing mechanical debridement of chronic leg ulcers, the application of lidocaine-prilocaine cream (LPC) resulted in significantly lower pain levels compared to nitrous oxide-oxygen mixture (NOOM) inhalation, with pain scores showing a marked difference (5.29 vs. 3.68 on the Visual Analog Scale).

Both treatments were found to be equally safe and effective in terms of the quality of debridement and tolerability, but LPC was clearly superior for pain management during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pain associated with debridement of leg ulcers: a randomized, multicentre, pilot study comparing nitrous oxide-oxygen mixture inhalation and lidocaïne-prilocaïne cream. Claeys, A., Gaudy-Marqueste, C., Pauly, V., et al.[2013]

Effective wound healing requires that the wound is clean, healthy, and free of infection, with surgical débridement being the fastest method to prepare the wound for healing.

After débridement, advanced treatments like growth factors, hyperbaric oxygen, and skin graft substitutes can be used to enhance healing, and plastic surgical techniques may be necessary for more complex closures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical débridement. The key to successful wound healing and reconstruction. Attinger, CE., Bulan, E., Blume, PA.[2019]

The article reviews six methods of wound debridement—surgical, mechanical, autolytic, enzymatic, chemical, and biological—highlighting their unique advantages and limitations in promoting wound healing.

Despite the advancements in wound management and debridement techniques, there is no consensus in the literature on the most effective method, indicating a need for further research and standardization in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current methods for wound debridement]. Iuonuţ, AM., Gongănău, DN., Precup, CG., et al.[2011]

Hydrocolloid dressings play a crucial role in the debridement process and treatment of venous leg ulcers by maintaining a moist wound environment, which supports the body's natural healing mechanisms.

Systematic debridement, combined with the use of hydrocolloid dressings, can enhance the internal healing processes and improve the micro-environment of chronic wounds affected by venous leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of hydrocolloid dressings in the process of debridement and treatment of venous leg ulcers]. Szewczyk, MT., Jawień, A.[2006]

In a rodent model of chronically infected wounds, both collagenase and papain-urea enzymatic debriding agents significantly reduced bacterial levels to below 10^5 Colony Forming Units per gram of tissue, indicating their effectiveness even in heavily infected wounds.

Wounds treated with these enzymatic agents healed faster and more completely compared to saline-treated controls, suggesting that their mechanism of action involves not only bacterial reduction but also enhanced wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzymatic debriding agents are safe in wounds with high bacterial bioburdens and stimulate healing. Payne, WG., Salas, RE., Ko, F., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on wound healing and efficacy of various leg ulcer debridement techniques. Doerler, M., Reich-Schupke, S., Altmeyer, P., et al.[2012]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6486053/

Debridement for venous leg ulcers - PMC - PubMed Central

A venous ulcer with an area less than 5 cm² and a duration of less than six months at baseline (at start of treatment) are two positive predictors of healing at ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10956538/

How effective is simple mechanical wound debridement in ...

One mechanical debridement achieved a significant reduction of bacterial colonised areas by an average of 29.6% in the wounds, 18.9% in the ...

3.

news.med.miami.edu

news.med.miami.edu/grant-funds-research-debridement-venous-leg-ulcers/

$2.7 Million Grant Funds Research into Effective Debridement ...

This article discusses a $2.7 million grant that will fund research into effective debridement methods for patients with venous leg ulcers.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06568627

A Double Blind Study Performed to Evaluate the Efficacy ...

The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound ...

5.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00329-8/fulltext

Once daily Bromelain-based enzymatic debridement of ...

Non-surgical debridement of venous leg ulcers has thus far not been demonstrated to lead to earlier wound closure. A faster debridement as seen ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK507882/

Wound Debridement - StatPearls - NCBI Bookshelf

The primary goal of debridement is to remove all the devitalized tissue from the wound bed to promote wound healing.

7.

aafp.org

aafp.org/pubs/afp/issues/2020/0201/p159.html

Chronic Wounds: Evaluation and Management

Effect of sharp debridement using curette on recalcitrant nonhealing venous leg ulcers: a concurrently controlled, prospective cohort study.

8.

cochrane.org

cochrane.org/evidence/CD008599_debridement-venous-leg-ulcers

Debridement for venous leg ulcers

The removal of devitalised tissue from venous ulcers (debridement) by any one of six methods helps to promote healing.