In short
A new drug called AUP1602-C is being studied in clinical trials as a potential treatment for non-healing diabetic foot ulcers. This topical medication is being tested to evaluate its safety, tolerability, and effectiveness in patients with diabetes who have foot ulcers that are not responding to standard care. The trial aims to determine the best dosing frequency and assess various aspects of wound healing and patient quality of life.
At a glance
- Drug Name
- AUP1602-C
- Condition Treated
- Non-healing neuro-ischemic diabetic foot ulcers
- Administration Method
- Topical application
- Study Phase
- Phase 2
- Primary Objectives
- Assess safety, tolerability, and efficacy of AUP1602-C
- Key Inclusion Criteria
- Adults with diabetes, non-healing foot ulcer for 4-12 months, ulcer size 1-10 cm²
- Primary Endpoints
- Incidence of adverse events, proportion of patients achieving complete wound closure within 20 weeks
- Secondary Endpoints
- Wound area reduction, time to wound closure, quality of life changes, pain reduction
- Follow-up Period
- Up to 12 months after last dose
What is AUP1602-C?
AUP1602-C is an innovative medical treatment being developed to help heal diabetic foot ulcers that are not responding well to standard care. It comes in the form of a cell suspension, which is a liquid containing living cells, and is applied directly to the wound (topically).
How does AUP1602-C work?
AUP1602-C is a type of advanced therapy that uses genetically modified organisms (GMOs). Specifically, it contains modified Lactococcus lactis bacteria, which are typically found in dairy products. These bacteria have been engineered to produce three important proteins:
- FGF-2 (Fibroblast Growth Factor 2): Helps in the formation of new blood vessels and promotes wound healing
- IL-4 (Interleukin 4): Reduces inflammation and supports wound healing
- CSF-1 (Colony Stimulating Factor 1): Stimulates the immune system and aids in tissue repair
By delivering these beneficial proteins directly to the wound site, AUP1602-C aims to accelerate the healing process in stubborn diabetic foot ulcers.
What conditions does AUP1602-C treat?
AUP1602-C is specifically being developed to treat non-healing neuro-ischemic diabetic foot ulcers. These are wounds on the feet of people with diabetes that:
- Have been present for at least 4 weeks and up to 12 months
- Are not improving with standard care
- Are caused by a combination of nerve damage (neuropathy) and poor blood flow (ischemia)
Diabetic foot ulcers can be serious complications of diabetes, potentially leading to infections and, in severe cases, amputations. Finding effective treatments for these hard-to-heal wounds is crucial for improving the quality of life for people with diabetes.
Current Research on AUP1602-C
AUP1602-C is currently being studied in a Phase 2 clinical trial. This means that while it has shown promise in earlier studies, it is still considered experimental and is not yet approved for general use. The ongoing study aims to:
- Evaluate the safety and tolerability of AUP1602-C
- Determine how effective it is in healing diabetic foot ulcers
- Compare different dosing schedules to find the most effective treatment plan
The researchers will be looking at various aspects of wound healing, including:
- How many patients achieve complete wound closure within 20 weeks
- How quickly the wounds heal
- Changes in wound size, depth, and volume
- Effects on quality of life and pain levels
- Rates of complications such as infections or need for amputations
Who can participate in the study?
The study is looking for adults (18 years and older) with diabetes who have a foot ulcer that meets specific criteria. Some key requirements include:
- Having a diabetic foot ulcer that has not improved much with standard care
- The ulcer must be between 1.0 and 10.0 square centimeters in size
- The ulcer must not involve bone or joints
- Participants must have adequate blood flow to the affected foot
- Participants must be willing to use special off-loading footwear to reduce pressure on the wound
There are also several conditions that would prevent someone from participating, such as certain medical conditions, medications, or treatments that could interfere with wound healing or the study results.
What to expect during the study
If selected for the study, participants will be randomly assigned to receive either AUP1602-C or a placebo treatment, in addition to standard wound care. The treatment will be applied directly to the wound. Participants will need to:
- Attend regular clinic visits for wound care and assessments
- Have their wound photographed and measured
- Complete questionnaires about their pain levels and quality of life
- Report any side effects or changes in their health
The study will last for 20 weeks of treatment, with additional follow-up visits up to 12 months after the last treatment.
Potential Benefits and Risks
While AUP1602-C shows promise, it's important to remember that it is still an experimental treatment. Potential benefits may include faster wound healing and reduced risk of complications. However, as with any medical treatment, there may be risks or side effects that are not yet known.
The study is designed to carefully monitor participants for any adverse effects. If you're considering participating in this or any clinical trial, it's crucial to discuss the potential risks and benefits with your healthcare provider.