Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Procedure: Wound Edge Debridement; Other: Standard of Care Treatment

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aliette Espinosa; Phone Number: 305-689-3376; Email: a.espinosa2@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Aliette Espinosa; Phone Number: 305-689-3376; Email: a.espinosa2@med.miami.edu
      • Principal Investigator: Marjana Tomic-Canic, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. >18 years of age
2. 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)
3. have a venous ulcer between the knee and ankle, at or above the malleolus
4. wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone
5. wound duration of at least 6 months
6. VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue
7. ability of subject to tolerate limb compression bandage

Exclusion Criteria:

1. history of diabetes mellitus and a HbA1c > 12% (obtained within past 6 months)
2. Ankle brachial index(ABI) less than 0.80
3. any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years
4. suspicion of malignancy within VLU
5. life expectancy <6 months
6. history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months)
7. history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) >2x upper limit of normal (obtained within past 6 months)
8. requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry
9. history of immunodeficiency
10. ulcers due to none venous etiology and leg ulcers associated with mixed etiology
11. Untreated osteomyelitis
12. Hepatitis
13. acute deep venous thrombosis
14. allergy to lidocaine and/or epinephrine
15. Subject's inability to successfully tolerate compression therapy that is changed weekly
16. Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors)
17. if currently incarcerated
18. known pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wound Edge Debridement Group; Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.	Procedure: Wound Edge Debridement; Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.; Other: Standard of Care Treatment; Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
Active Comparator: Standard care group; Participants in this group will receive only the standard care of treatment for up to 4 weeks.	Other: Standard of Care Treatment; Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the genetic profile after debridement in the intervention group.	RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent rate of healing	Percent rate of healing is measured at every weekly visit and divided by 4 to calculate the average percent wound healing rate in cm2/week.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Marjana Tomic-Canic, PhD, University of Miami; Principal Investigator: Robert Kirsner, MD/PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 20180256; R01AR073614 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No