DermaBind TL for Venous Ulcers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called DermaBind TL, designed to heal chronic non-healing wounds, specifically venous ulcers. Researchers aim to evaluate the treatment's effectiveness, safety, and patient tolerance. The trial seeks participants with diabetes and a stubborn foot ulcer that hasn't healed in over four weeks but less than a year. Participants should have no infection in the ulcer and must have good circulation in the affected foot. Those who meet these criteria might consider joining to help advance this new treatment option. As a Phase 4 trial, this research focuses on understanding how DermaBind TL, already FDA-approved and proven effective, can benefit more patients.
Do I need to stop taking my current medications for the trial?
The trial requires that participants with Type I or Type II diabetes must have been on a stable anti-diabetic treatment for at least 30 days before joining. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the trial team.
What is the safety track record for DermaBind TL?
Research shows that DermaBind TL is generally safe. In earlier studies, people with various ulcers, including pressure and diabetic foot ulcers, used DermaBind TL. The treatment showed few safety concerns, with most issues being mild, such as skin irritation. These results suggest that DermaBind TL is safe for humans. Additionally, since this trial is in a later stage, the treatment has undergone previous testing with good safety outcomes.12345
Why are researchers enthusiastic about this study treatment?
DermaBind TL is unique because it uses a dehydrated placental membrane tissue allograft, which is not commonly used in the standard care for venous ulcers. Most treatments focus on offloading pressure, debridement, and infection management, but DermaBind TL adds a biological component that may enhance healing by providing a natural scaffold for tissue regeneration. Researchers are excited because this approach could potentially improve healing rates and outcomes by harnessing the body's natural healing mechanisms in a novel way.
What is the effectiveness track record for DermaBind TL in treating venous ulcers?
Research shows that DermaBind TL, the treatment under study in this trial, effectively treats venous ulcers, which are long-lasting wounds that are hard to heal. Studies have found that patients using DermaBind TL experienced significant healing in about 6.7 weeks. In a study with 27 patients and 36 wounds, the treatment showed promising results in closing wounds and improving their condition. The treatment uses a special placental membrane tissue that aids healing by covering and protecting the wound. This makes it a useful option for managing ulcers that don't heal easily, potentially speeding up healing and increasing patient comfort.13678
Who Is on the Research Team?
Stan Andrews, MS
Principal Investigator
Professional Education and Research Institute
Are You a Good Fit for This Trial?
Adults aged 18-80 with chronic non-healing ulcers, specifically diabetic foot ulcers (DFU) grades 1 or 2. Participants must have stable diabetes treatment for at least 30 days, an A1C ≤10%, a single target ulcer not probing to bone and distant from other wounds, and no infection as confirmed by radiographic evidence.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DermaBind TL™ for the management of non-healing ulcers over a 12-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment, including wound area preservation and infection rates
What Are the Treatments Tested in This Trial?
Interventions
- DermaBind TL
Trial Overview
The trial is testing DermaBind TL™ on patients with chronic non-healing wounds like venous ulcers and diabetic foot. It's an open-label study which means everyone knows they're getting the test product, aiming to assess its effectiveness in healing these types of wounds.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The SOC therapy in this study is offloading of the DFU or VLU (Foot Defender® CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM Boot), appropriate sharp or surgical debridement, infection management and wound care covering with dehydrated Placental membrane tissue allograft (DERMABIND TL™), and a non-adherent dressing, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthTech Wound Care
Lead Sponsor
Citations
A Non-Randomized Open Label Clinical Trial Evaluating ...
This clinical trial will assess the effectiveness of HealthTech Wound Care's medical intervention with the use of DermaBind TL™. HealthTech ...
Clinical use of DermaBind TL/FM as a wound covering for ...
Results: The cases of 27 patients encompassing 36 wounds were included. The average age of patients included was 72.4 years (range: 37-101 years) ...
Clinical use of DermaBind TL/FM as a wound covering for ...
Data collected included patient demographics, wound characteristics and wound size. Results: The cases of 27 patients encompassing 36 wounds ...
Review of the current evidence for topical treatment ...
In the present review, we focused on describing the rationale and scientific basis for topical wound care in the management of VLUs.
5.
linkedin.com
linkedin.com/posts/world-reach-health-llc_real-world-wounds-are-complex-chronic-and-activity-7394041235755126784-D8fkDermaBind TL/FM heals hard-to-heal wounds in 6.7 weeks
➡️Evidence ⬇️ Pain and quality of life for patients with venous leg ulcers: proof of concept of the efficacy of Biatains-Ibu, a new pain ...
Venous Leg Ulcers (VLU) (DBCOND0147916)
A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers. No drug interventions, other, 4 ...
Clinical use of DermaBind TL/FM as a wound covering for ...
ulcers (PUs), diabetic foot ulcers (DFUs), venous leg ulcers. (VLUs) and ... Method: This retrospective observational, uncontrolled case series collected data ...
Upcoming Update to the Final Local Coverage ...
The LCDs provide access to multiple evidence-based skin substitute products for Medicare beneficiaries with diabetic foot ulcers and venous leg ...
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