Amnio-Maxx for Foot Ulcer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Amnio-Maxx to see if it aids in healing diabetic foot ulcers when combined with standard care. The goal is to determine if this treatment improves healing for individuals with difficult-to-treat ulcers. Participants should have a diabetic foot ulcer that hasn't significantly healed in the past two weeks despite standard treatment. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from innovative treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, certain chemotherapy, or topical steroids, you may need to stop these before joining the trial.
What prior data suggests that Amnio-Maxx is safe for use in patients with diabetic foot ulcers?
Research has shown that Amnio-Maxx, a treatment using amniotic membrane, is generally safe for people with diabetic foot ulcers. Studies indicate no major differences in negative side effects compared to other treatments, meaning serious side effects are rare.
Although detailed data remains limited, the treatment has been used in other studies for similar conditions with a good safety record. For those considering joining a trial with Amnio-Maxx, current evidence suggests it is well-tolerated.12345Why are researchers excited about this trial?
Amnio-Maxx is unique because it incorporates amniotic membrane technology, which is not typical in standard treatments for foot ulcers. While most treatments focus on debridement, offloading, and maintaining moisture balance to promote healing, Amnio-Maxx offers a new approach by potentially enhancing tissue regeneration and reducing inflammation. Researchers are excited about this treatment because it might accelerate healing and improve outcomes for patients with foot ulcers, offering a promising alternative to existing care methods.
What evidence suggests that Amnio-Maxx is effective for diabetic foot ulcers?
Research has shown that treatments using amniotic membrane, such as Amnio-Maxx, can aid in healing diabetic foot ulcers. In this trial, some participants will receive Amnio-Maxx alongside standard care. One study found that 69% of wounds treated with Amnio-Maxx healed completely in 12 weeks, compared to 47% with standard care alone. These findings suggest that Amnio-Maxx might accelerate healing for persistent foot ulcers. Another study supports the use of similar products, demonstrating improved healing rates. The evidence indicates that Amnio-Maxx could be a promising addition to standard foot ulcer treatments.12567
Who Is on the Research Team?
Marissa Docter, RN, BSN, MD
Principal Investigator
Capsicure, LLC
Windy Cole, DPM
Principal Investigator
Capsicure, LLC
Are You a Good Fit for This Trial?
This trial is for adults over 18, with Type I or II Diabetes Mellitus and a diabetic foot ulcer present for more than 4 weeks but less than a year. The ulcer should be between 2.0 cm² and 25 cm² in size after cleaning, not healing well, and have adequate blood flow to the foot. People over 65 are especially encouraged to join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants complete a 2-week run-in period prior to treatment allocation
Treatment
Participants receive Amnio-Maxx and standard of care or standard of care alone for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amnio-Maxx
Find a Clinic Near You
Who Is Running the Clinical Trial?
Capsicure, LLC
Lead Sponsor