Venous Leg Ulcer
Conditions
Brief 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.
Interventions
PROCEDUREWound 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.
OTHERStandard of Care Treatment
Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
Sponsors
University of Miami
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Genetic Profile After Debridement in the Intervention Group. | Baseline and 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group | Baseline to 4 weeks | Wound size is measured at every weekly visit. If the wound size decreased by 50% from baseline to week 4, the participant in considered having a "healing wound". If the wound size does not decreased by 50% from baseline to week 4, the participant is considered a "non-healing wound". |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarjana Tomic-Canic, PhD
University of Miami
PRINCIPAL_INVESTIGATORRobert Kirsner, MD/PhD
University of Miami
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 14 |
| other Total, other adverse events | 0 / 27 | 0 / 14 |
| serious Total, serious adverse events | 1 / 27 | 0 / 14 |
Outcome results
None listed