Pure: Proteome Analysis of Urgo Clean Ag-Treated Regenerative Wound Exudate

Investigating Venous Leg Ulcer Wound Healing Through Observational Study

M
Mithun Sinha

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
10 participants needed
1 Location

Brief description of study

Single-site, prospective, observational/specimen-collection pilot embedded in standard-of-care venous leg ulcer (VLU) management. One target dressing will be collected after 7 days of wear for proteomic analysis. 

THIS STUDY IS ENROLLING BY INVITATION ONLY - This study is enrolling adults (≥18 years) with a chronic VLU receiving standard compression therapy and presenting with significant wound slough/devitalized tissue. Once the research staff has determined that the subject is eligible for the study through prescreening for inclusion and exclusion, approved research staff will approach the patient at one of their regularly scheduled visits at the Comprehensive Wound Center (CWC) in a private room.

Detailed description of study

Single-site, prospective, observational/specimen-collection pilot embedded in standard-of-care venous leg ulcer (VLU) management. One target dressing will be collected after 7 days of wear for proteomic analysis.

Visit 1: Screening/Baseline (Day 0). Visit 2: Day 7 (±1 day). Optional chart review at ~3 months.

Baseline cleansing with Vashe® gel (soak 5 minutes, wipe with gauze) followed by application of URGO Clean Ag™ dressing and standard compression wrap. Day 7 (±1 day) removal and collection of the used dressing for laboratory proteomics testing; clinical care continues per clinician.  All products are used within labeled indications as part of standard care; the research activity is collection and laboratory analysis of the used dressing.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Wound slough, devialitzed tissue
  • Age: 18 years - 100 years
  • Gender: All

Inclusion criteria:

Adults (≥18 years) with a chronic VLU receiving standard compression therapy and presenting with significant wound slough/devitalized tissue.

This study investigates how venous leg ulcers (VLUs) heal when treated with a special type of dressing. VLUs are wounds that occur when the veins in the legs do not circulate blood back to the heart properly, leading to skin breakdown and open sores. This study is observational, meaning it collects information by watching participants receive their usual care without changing their treatment. The study will collect a dressing after it has been used for seven days to analyze the proteins involved in the healing process.

Participants in the study will have their wounds treated with a special dressing called URGO Clean Ag™ and standard compression therapy. After seven days, the dressing will be removed and sent for laboratory testing to study the proteins in the wound fluid. The study also involves a baseline cleansing process using a gel and gauze to clean the wound before applying the dressing. All treatments are part of the usual care for VLUs.

  • Who can participate: Adults aged 18 and older with chronic venous leg ulcers receiving standard compression therapy and having significant wound slough or devitalized tissue can participate.
  • Study details: Participants will have a special dressing applied to their wound, which will be collected after seven days for analysis. The study involves routine wound care and collection of the used dressing for laboratory testing.
  • Study visits: The study requires 2 visits.
Updated on 10 Jun 2026. Study ID: SURG-URGO-PURE, 31225
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only