Are you struggling with nonhealing foot or leg ulcers?
Overview of the trial
You might be able to join a study testing new treatments for slow-healing diabetic foot ulcers and leg ulcers caused by vein problems. This study compares a new treatment plus regular care to regular care alone. The goal is to see which approach helps wounds heal better by week 12.
What are the benefits?
You might be able to join a study testing new treatments for slow-healing diabetic foot ulcers and leg ulcers caused by vein problems. This study compares a new treatment plus regular care to regular care alone. The goal is to see which approach helps wounds heal better by week 12.
Trial Process
You will start with a screening visit where we will review your medical history and do some tests to see if you can join the study. This includes a physical exam, blood tests, and checks related to your wound and overall health.
If you qualify and agree to participate, you will sign a consent form. Then, you will be randomly placed into one of three groups: one will receive AmnioExcel® Plus with standard care, another will get Cytal® Wound Matrix with standard care, and the third will receive standard care alone.
The treatment will last for 7 weeks. During this time, you will visit the clinic every week for check-ups. These visits will include looking at your wound, checking your vital signs, and watching for any side effects or health changes.
About 2 weeks after finishing the treatment, you will have a follow-up visit to see how you are doing.
Throughout the study, we will carefully monitor your safety and how well the treatments work. If your foot ulcer is on the bottom of your foot, you will be asked to use special offloading methods to help healing. You need to attend all scheduled visits.
This process helps us learn how safe and effective these treatments are while making sure you get good medical care.
Trial Goals
Trial Goals
- AmnioExcel® Plus
AmnioExcel® Plus is a special treatment made from human placental tissue. It is used to help cover and protect soft tissue wounds. A healthcare professional applies it as a dried membrane during wound healing.
The product contains tiny amounts of alcohol (ethanol). Do not use it if you are sensitive to alcohol or if you have an active infection.
- The aim of this trial
This study wants to see if adding CAMP to the usual treatment helps heal diabetic foot ulcers or leg ulcers caused by veins better than usual treatment alone. It will check how many ulcers are fully healed by week 12 and how fast they heal. The study also looks at how well this treatment works for people aged 65 and older. It will also watch for any side effects and see if the treatment improves quality of life.
Requirements for participants
- To join the study, you need to:
- Be at least 21 years old.
- Have either type 1 or type 2 diabetes.
- Have a foot ulcer that has been there for at least 4 weeks but no more than 52 weeks.
- Be able to use a special device to protect your foot ulcer as instructed.
- Be willing to come to weekly study visits and agree to the consent process.
- You should not join if:
- You have less than 6 months to live.
- You are pregnant or planning to become pregnant soon.
- You have serious health problems like end-stage kidney disease.
- You are allergic to any study materials.
Integra LifeSciences, Corp.
- Integra LifeSciences, Corp.
This study wants to see if adding CAMP to the usual treatment helps heal diabetic foot ulcers or leg ulcers caused by veins better than usual treatment alone. It will check how many ulcers are fully healed by week 12 and how fast they heal. The study also looks at how well this treatment works for people aged 65 and older. It will also watch for any side effects and see if the treatment improves quality of life.
