Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Wound Edge Debridement

Intervention Type PROCEDURE

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.

Standard of Care Treatment

Intervention Type OTHER

Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.

Standard care group

Participants in this group will receive only the standard care of treatment for up to 4 weeks.

Group Type ACTIVE_COMPARATOR

Standard of Care Treatment

Intervention Type OTHER

Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.

Interventions

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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.

Intervention Type PROCEDURE

Standard of Care Treatment

Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No