Diabetes can lead to foot ulcers which can lead to serious complications.
When the sores are open, they’re called ulcers and can become infected. The infected ulcer can lead to an infection in the foot bone and become very serious. If left untreated, a neglected ulcer can lead to amputation.
People with diabetes often develop peripheral neuropathy, or damaged nerves, in their feet related to low blood flow. These damaged nerves and low blood flow can lead to numbness and tingling as well as sores and blisters.
This study is to learn whether phage can effectively treat diabetic foot ulcers.
What to expect as a part of this trial:
First see if you meet three basic qualifications and you'll be directed to a clinic in your area. They will set up a time with you to finish the screening process. If you are a match and want to participate, they'll walk you through the steps for enrollment and informed consent process.
Patients choosing to participate in this study will be asked to undergo screening tests (such as blood tests, wound cultures, and bone biopsy) or procedures to find out if they are eligible.
What are phage?
Bacteriophage, also known as “phage,” are natural viruses that kill bacteria. They do not infect humans. They are the most abundant biological entities found in nature. Phage are found in all parts of the body and play a key role in the natural healthy balance of bacteria. We are continuously exposed to many kinds of phage.
Participation in Adaptive Phage Therapeutics’ clinical trials provides an opportunity to play an important role in development of phage as a potential treatment for difficult bacterial infections.
A publication in the Journal of the American Medical Association highlights promising case studies demonstrating the potential benefits of phage therapy. While the case studies are promising, the article emphasizes the need for controlled-clinical trials to progress phage therapy.
How is phage therapy different from traditional antibiotics?
Phage therapy has immense potential as an alternative to traditional antibiotics in treating bacterial infections.
Highly targeted: Antibiotics kill both harmful and beneficial bacteria. On the other hand, phage target only the harmful bacteria.
Self-dosing: Phage replicate at the site of the infection, maximizing the effective dose where they're needed most.
Adaptive: Bacteria can become resistant to antibiotics while APT's phage therapy is dynamic and adapts to avoid resistance.
Safety: Phage safety has been demonstrated in various studies and clinical trials. APT's clinical trials are designed to continuously assess the safety of phage therapy.
Avoiding amputation: For some of the most difficult infections, phage holds promise for avoiding amputations.
What are the benefits of participating in this clinical trial?
Clinical trials are an essential part of the drug development process. Participating in Adaptive Phage Therapeutic's clinical trials is a deeply personal decision for you and your family.
Financial compensation: participants may receive financial compensation for time and travel.
Access to cutting-edge treatments: clinical trials provide access to treatments not yet available to the general public.
Contributing to medical research: participants can contribute to the development of new treatments for bacterial infections.
Close monitoring and care: this can be especially important for participant with bacterial infections who require specialized care.
Potential for improved outcomes: participants may benefit from new or better investigational medication not currently available to the public.
Purpose: This study is to learn whether phage, viruses designed to attack bacteria, are a safe and effective form of treatment for foot ulcers associated with foot bone infections in patients with diabetes.
Interested in joining this trial?
Just 3 simple questions to get started:
1 Are you between 18 and 85 years old?
2 Do you have diabetes?
3 Do you have a foot ulcer?
Note: Other conditions not specified above may result in exclusion from the study.
If you answer yes to all three questions,
you may qualify to participate in a research study that may help.