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Aup1602-C

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.

Table of Contents

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[1]. It comes in the form of a cell suspension, which is a liquid containing living cells, and is applied directly to the wound (topically)[1].

How does AUP1602-C work?

AUP1602-C is a type of advanced therapy that uses genetically modified organisms (GMOs)[1]. 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[1].

What conditions does AUP1602-C treat?

AUP1602-C is specifically being developed to treat non-healing neuro-ischemic diabetic foot ulcers[1]. 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[1].

Current Research on AUP1602-C

AUP1602-C is currently being studied in a Phase 2 clinical trial[1]. 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:

  1. Evaluate the safety and tolerability of AUP1602-C
  2. Determine how effective it is in healing diabetic foot ulcers
  3. Compare different dosing schedules to find the most effective treatment plan

The researchers will be looking at various aspects of wound healing, including[1]:

  • 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[1]:

  • 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[1].

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[1]:

  • 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[1].

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[1].

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[1].

Aspect Details
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

FAQ

  • What is AUP1602-C? AUP1602-C is an investigational topical treatment for non-healing diabetic foot ulcers. It is a cell suspension containing genetically modified bacteria designed to promote wound healing.
  • Who can participate in this clinical trial? The trial is open to adults (18 years and older) with diabetes who have a non-healing foot ulcer that has lasted between 4 weeks and 12 months. Participants must meet specific criteria regarding ulcer size, location, and overall health status.
  • How is AUP1602-C administered? AUP1602-C is applied topically to the wound. The study is testing two different dosing frequencies to determine which is most effective.
  • What are the main goals of this clinical trial? The primary goals are to assess the safety and tolerability of AUP1602-C and to evaluate how many patients achieve complete wound closure within 20 weeks of starting treatment.
  • How long does the clinical trial last? The main treatment period lasts 20 weeks, with follow-up assessments continuing for up to 12 months after the last dose to monitor long-term healing and potential ulcer recurrence.

Ongoing Clinical Trials on Aup1602-C

  • Study on AUP1602-C for Treating Non-Healing Diabetic Foot Ulcers in Patients

    Not yet recruiting

    2 1 1
    Investigated drugs:
    Italy

  • Study on AUP1602-C for Treating Non-Healing Diabetic Foot Ulcers in Patients

    Not recruiting

    2 1
    Investigated drugs:
    Germany Italy Poland

Glossary

  • Diabetic Foot Ulcer (DFU): An open sore or wound that occurs in people with diabetes, typically on the bottom of the foot. These ulcers can be slow to heal due to complications of diabetes.
  • Topical Treatment: A medication or therapy that is applied directly to the skin or affected area, rather than taken orally or injected.
  • Standard of Care (SoC): The typical treatment or care given to patients with a specific condition, based on current medical knowledge and practices.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs. In this study, some patients will receive a placebo in addition to standard care.
  • Colony Forming Units (CFU): A measure used to estimate the number of viable bacteria or fungal cells in a sample. In this study, the dose of AUP1602-C is measured in CFUs.
  • Glycosylated Hemoglobin (HbA1c): A blood test that measures average blood sugar levels over the past 2-3 months. It's used to diagnose and monitor diabetes.
  • Ankle Brachial Index (ABI): A test that compares blood pressure in the ankle to blood pressure in the arm, used to check for peripheral artery disease.
  • Quality of Life (QoL): A measure of an individual's overall well-being and ability to function in daily life, often assessed in clinical trials to determine how a treatment affects patients beyond just physical symptoms.
  • Genetically Modified Organism (GMO): An organism whose genetic material has been altered using genetic engineering techniques. AUP1602-C contains genetically modified bacteria.
  • Periwound: The area of skin immediately surrounding a wound or ulcer.

References

  1. http://clinicaltrials.eu/trial/study-on-aup1602-c-for-treating-non-healing-diabetic-foot-ulcers-in-patients/