A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
{ "DermaBind TL for Diabetic Foot Ulcers and Venous Leg Ulcers", "This study is looking at how well a treatment called DermaBind TL works for people with chronic non-healing wounds like diabetic foot ulcers (DFU) or venous leg ulcers (VLU). DermaBind TL is a special wound covering made from placental tissue. The researchers want to see if it helps protect the wound, how safe it is, and if it's well-tolerated. They will also look at things like how much the wound area changes, infection rates, and if the wounds come back after treatment. You might be able to join if you are between 18 and 80 years old and have a DFU that meets specific criteria. The study aims to enroll 150 participants, but its current status is unclear.", "design": "This is a single-arm study, meaning all participants will receive the DermaBind TL treatment. It is an open-label study, so both you and your doctors will know you are receiving DermaBind TL.", "commitments": "You would receive DermaBind TL applied to your wound over a 12-week treatment period. Wound assessments will be conducted by a clinician at each site.", "compensation": "Not stated in the trial record.", "follow_up": "The primary goal is to measure the protective effect of the wound covering over a 13-week period. The study will also look at wound reoccurrence post-treatment through the end of study (EOS), but the duration of this follow-up is not specified.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
At a glance
Conditions
Where it's being run
10 sites across 6 statesStudy leadership
- Stan Andrews, MS · STUDY_DIRECTOR · Professional Education and Research Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Measure the protective effect of the wound covering on the wound over the 13-week treatment period13 weeks
Size of wound will be measured using Clock method * 12 o'clock to 6 o'clock: Measure the length of the wound from the top (12 o'clock) to the bottom (6 o'clock). * 9 o'clock to 3 o'clock. Measure the width of the wound from the left (9 o'clock) to the right (3 o'clock). * Depth Measurement: Use a cotton tip applicator to measure the depth. Insert the applicator gently into the deepest part of the wound, mark the point where it meets the wound edge, and measure the length from the tip to the mark. * The area is then calculated as: Area (cm2) = Length (cm) × Width (cm), where length is the longest axis of the index ulcer and width is the longest orthogonal at an axis 90 degrees relative to the length.