Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

Official title:

Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03796793
• Other study ID #: 20180256
• Secondary ID: R01AR073614
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: Aliette Espinosa
• Phone: 305-689-3376
• Email: a.espinosa2[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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