Placental Membrane Dressings for Foot Ulcer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to heal foot ulcers, painful sores common in people with diabetes. The treatment uses placental membrane dressings, believed to speed up healing. Participants will either receive this new dressing or be compared to past patient records to evaluate its effectiveness. Those with a diabetic foot ulcer lasting over four weeks and not healing well with usual care may qualify for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using certain treatments like chronic oral steroids, advanced biological therapies, or topical anti-microbial products. It's best to discuss your specific medications with the trial team.
What is the safety track record for the placental membrane dressing?
Research has shown that placental membrane dressings are generally safe for treating foot ulcers. One study found these dressings effective and safe, with results comparable to standard wound treatments. Another study found no major differences in side effects when comparing placental membrane treatments to other methods, indicating good patient tolerance. Additionally, placental tissues contain special cells that promote faster wound healing, leading to quicker recovery and better outcomes without additional safety concerns.12345
Why are researchers enthusiastic about this study treatment?
Placental membrane dressings are unique because they utilize natural biological materials to aid the healing of foot ulcers. Unlike traditional treatments like debridement, antibiotic creams, or synthetic dressings, placental membranes contain growth factors and proteins that can accelerate tissue repair and reduce inflammation. Researchers are excited about this approach as it offers a potentially more effective and faster healing process, tapping into the body's own regenerative capabilities. Additionally, the use of placental membranes might reduce the need for more invasive procedures, providing a gentler and innovative alternative for patients.
What evidence suggests that placental membrane dressings are effective for diabetic foot ulcers?
Research has shown that placental membrane dressings, which participants in this trial will receive, effectively treat diabetic foot ulcers. Studies have found that these dressings help wounds close faster and heal more quickly than regular treatments. Placenta-derived materials have been more successful than standard methods in fully healing ulcers. This success likely stems from placental tissues containing special cells, called mesenchymal stem cells, that aid in tissue repair and growth. Overall, these findings suggest that placental membrane dressings can significantly improve treatment outcomes for foot ulcers.12356
Are You a Good Fit for This Trial?
This trial is for adults with Type 1 or Type 2 diabetes who have a diabetic foot ulcer (DFU) below the ankle, sized between 1.0 cm² and 20.0 cm² that's been present for at least four weeks but no more than one year. The ulcer should not be healing well on its own and must not show exposed muscle or bone.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive placental membrane dressings to evaluate their efficacy in accelerating diabetic foot healing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placental Membrane
Trial Overview
The study tests if placental membrane dressings can speed up the healing of diabetic foot ulcers compared to standard treatments. Participants will receive these special dressings to see if their wounds heal faster.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioXTek
Lead Sponsor
Citations
Assessing placental membrane treatment efficiency in ...
The findings suggest that while L‐AC might be slightly more effective in complete ulcer healing, RE‐AC offers overall better treatment efficiency.
Placenta-derived biomaterials vs. standard care in chronic ...
Placenta-derived biomaterials therapies have been shown to be more effective for achieving complete ulcer healing compared to current conventional treatments ...
Trial Assessing the Efficacy of Human Placental Membrane ...
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management ...
Placental Tissue Therapies for Diabetic Foot Ulcers
Studies found quicker closure of wounds, shorter healing times, and better outcomes with these treatments. Placental tissues contain mesenchymal stem cells and ...
A Multi‐Centre, Randomised, Controlled Clinical Trial ...
The primary efficacy endpoint was time in days to complete wound healing within the first 26 weeks or 182 days, which was calculated as the ...
The efficacy and safety of Grafix® for the treatment ...
The results of this well-controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.