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Gene-Guided surgery may boost healing of stubborn leg wounds

NCT ID NCT03796793

Knowledge-focused Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using genetic information to guide surgical cleaning (debridement) could improve healing in people with hard-to-heal venous leg ulcers. Researchers analyzed genes and proteins from wound samples before and after the procedure. The goal was to see if this personalized approach leads to better healing rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

41 people

The number who actually took part.

Started

Mar 2019

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous leg ulcer

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.