Venous Leg UlcerNCT03796793
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
A study testing Wound Edge Debridement in people with Venous Leg Ulcer, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Wound Edge Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Wound Edge Debridement, Standard of Care Treatment
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound Edge DebridementProcedure or surgery
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 TreatmentOther
Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
| Study group | Role | What they receive |
|---|---|---|
| Wound Edge Debridement Group | Experimental | Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks. Receives: Procedure: Wound Edge Debridement; Other: Standard of Care Treatment |
| Standard care group | Active comparator | Participants in this group will receive only the standard care of treatment for up to 4 weeks. Receives: Other: Standard of Care Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group
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".
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start18 Mar 2019
- Primary completion13 Feb 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Robert S. Kirsner, University of Miami
- Investigators
- Marjana Tomic-Canic, PhD, Principal investigator, University of MiamiRobert Kirsner, MD/PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796793
- Sponsor's protocol ID
- 20180256
- Other IDs
- R01AR073614
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2019
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03796793
- Acronym / sponsor ID
- 20180256
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound Edge Debridement Group | Experimental | Procedure: Wound Edge Debridement, Other: Standard of Care TreatmentParticipants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks. |
| Standard care group | Active comparator | Other: Standard of Care TreatmentParticipants in this group will receive only the standard care of treatment for up to 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound Edge DebridementWound 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. | Procedure or surgery | Wound Edge Debridement Group |
| Standard of Care TreatmentStandard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. | Other | Standard care group, Wound Edge Debridement Group |
Primary outcome
Change in the Genetic Profile After Debridement in the Intervention Group.
Time frame: 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.
1 secondary outcome
Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group
Time frame: Baseline to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjana Tomic-Canic, PhD principal investigator
University of Miami
Robert Kirsner, MD/PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Edge Debridement in people with Venous Leg Ulcer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Genetic Profile After Debridement in the Intervention Group. (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.