Back to results

Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Primary Purpose

Venous Leg Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wound Edge Debridement

Standard of Care Treatment

About this trial

This is an interventional basic science trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wound Edge Debridement Group

Standard care group

Arm Description

Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03796793

First Posted

January 3, 2019

Last Updated

July 18, 2023

Sponsor

University of Miami

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

1. Study Identification

Unique Protocol Identification Number

NCT03796793

Brief Title

Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Official Title

Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 18, 2019 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Wound Edge Debridement Group

Arm Type

Experimental

Arm Description

Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.

Arm Title

Standard care group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Wound Edge Debridement

Intervention Description

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

Other

Intervention Name(s)

Standard of Care Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the genetic profile after debridement in the intervention group.

Description

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.

Time Frame

Baseline and 4 weeks

Secondary Outcome Measure Information:

Title

Percent rate of healing

Description

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.

Time Frame

Up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: >18 years of age 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) have a venous ulcer between the knee and ankle, at or above the malleolus wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone wound duration of at least 6 months VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue ability of subject to tolerate limb compression bandage Exclusion Criteria: history of diabetes mellitus and a HbA1c > 12% (obtained within past 6 months) Ankle brachial index(ABI) less than 0.80 any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years suspicion of malignancy within VLU life expectancy <6 months history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months) history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) >2x upper limit of normal (obtained within past 6 months) requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry history of immunodeficiency ulcers due to none venous etiology and leg ulcers associated with mixed etiology Untreated osteomyelitis Hepatitis acute deep venous thrombosis allergy to lidocaine and/or epinephrine Subject's inability to successfully tolerate compression therapy that is changed weekly Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors) if currently incarcerated known pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aliette Espinosa

Phone

305-689-3376

a.espinosa2@med.miami.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marjana Tomic-Canic, PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Kirsner, MD/PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aliette Espinosa

Phone

305-689-3376

a.espinosa2@med.miami.edu

First Name & Middle Initial & Last Name & Degree

Marjana Tomic-Canic, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

We'll reach out to this number within 24 hrs